CrawlJobs Logo

Manager, Quality Control Microbiology

amgen.com Logo

Amgen

Location Icon

Location:
United States , Holly Springs

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

122421.00 - 142851.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

Manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring, clean utilities' monitoring, and routine microbiological testing to support drug substance manufacturing.

Job Responsibility:

  • Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing, and production in-process and final drug substance testing
  • Manage the training program for sampling and testing team
  • Assist with planning, scheduling, and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes
  • Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling, coordinating activities with manufacturing operations, reviewing and interpreting data, and writing trend reports
  • Act as Subject Matter Expert for method families and testing platforms used in the microbiology department
  • Work cross-functionally with Manufacturing, Analytical Sciences, Facilities & Engineering, and Quality teams to align processes with business needs
  • Author, revise, and review documents and reports including but not limited to: SOPs, safety assessments, trend reports, qualification/validation summary reports, microorganism assessments, and technical reports
  • Represent the microbiology department during agency inspections and internal audits
  • Work closely with the global Quality Control organization to drive standardization of testing processes and procedures
  • Own, manage, and participate in deviations, CAPAs, and cross functional investigations
  • Lead process improvement projects that may be local or global in scope
  • Support routine activities over the weekends and public holidays as required

Requirements:

  • High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience
  • Associate’s degree and 10 years of Quality or Aseptic Manufacturing experience
  • Bachelor’s degree and 5 years of Quality or Aseptic Manufacturing experience
  • Master’s degree and 3 years of Quality or Aseptic Manufacturing experience
  • Doctorate degree
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have:

  • Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements
  • Degree in Microbiology, Biology, Biochemistry, or related scientific field
  • Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data
  • Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC
  • Experience with equipment validation
  • Solid understanding of aseptic technique
  • Strong written and verbal communication skills, including technical writing and technical presentations
  • Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer
What we offer:
  • Competitive and comprehensive Total Rewards Plans
  • Competitive benefits
  • Collaborative culture
  • Support for professional and personal growth and well-being

Additional Information:

Job Posted:
January 24, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Manager, Quality Control Microbiology

Associate Quality Control

The Associate Quality Control will provide analytical testing support for the Qu...
Location
Location
United States , Thousand Oaks
Salary
Salary:
66222.00 - 82012.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 2 years Quality Control experience
  • Associate’s + 6 months Quality Control work experience
  • Bachelor’s
Job Responsibility
Job Responsibility
  • Execution of QC Microbiology assays following assigned procedures
  • Analysis of analytical test results and reporting of raw data into various laboratory information management systems
  • Lab support activities such as management of lab consumables and equipment maintenance/work order completion
  • Operating specialized laboratory equipment
  • Daily communication and collaboration with cross-functional teams
  • Implementation of lab improvements to ensure an efficient and productive lab environment
  • Flexibility in work hours to support demand of work
  • occasional evening and/or weekend hours may be required
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Fulltime
Read More
Arrow Right

Manager Infection Prevention - Infection Control

In a High Reliability Organization, Manager Infection Prevention is responsible ...
Location
Location
United States , Corpus Christi
Salary
Salary:
Not provided
christushealth.org Logo
CHRISTUS Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Nursing, Microbiology, Clinical laboratory sciences, Epidemiology, Public Health, or other health-related field required
  • Associate degree nurses may also be considered
  • 5 years of healthcare or public health experience preferred
  • 3 years of experience as an Infection Preventionist preferred
  • 2 years of management experience preferred
  • CBIC CIC (Certification in Infection Control) upon hire
  • Must be proficient in computer skills using EXCEL, PowerPoint, MS Office, and Flowchart tools
  • Must communicate effectively to different audiences
  • Must be knowledgeable on High-Reliability Principles and PDSA methodology
Job Responsibility
Job Responsibility
  • Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders
  • Quality Leadership and Integration - Advance the organization's commitment to health care quality through collaboration, learning opportunities and communication
  • Performance and Process Improvement - Use performance and process improvement (PPI), project management and change management methods to support operational and clinical quality initiatives
  • Population Health and Care Transitions - Evaluates and improve health care processes and care transitions to advance the efficient, effective, and safe care of defined populations
  • Health Data and Analytics - Leverage the organizations analytic environment to help guide data-driven decision-making and inform quality improvement initiatives
  • Regulatory and Accreditation - Direct organization wide processes for evaluating, monitoring, and improving compliance with internal and external requirements
  • Patients Safety - Cultivate a safe healthcare environment by promoting safe practices, nurturing a just culture, and improving processes that detect, mitigate, or prevent harm
  • Quality Review and Accountability - Direct activities that support compliance with organization wide voluntary, mandatory, and contractual requirements for data acquisition, analysis, reporting, and improvement
  • Professional Engagement - Engage in the healthcare quality profession with a commitment to practicing ethically, enhancing one's competence, and advancing the field
  • Fulltime
Read More
Arrow Right

Quality Control Technician

The Quality Control Technician reports to the Quality Manager. S/he is responsib...
Location
Location
Canada , Hawkesbury
Salary
Salary:
Not provided
leclerc.ca Logo
Biscuits Leclerc Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associates degree in Food Science and Technology, Biology, or equivalent combination of education/experience
  • Minimum of 2 years’ experience in technical field (engineering, food science, chemistry) with industry experience
  • Knowledge of GFSI / BRC, SQF, GMP and other food safety standard including HACCP or similar food industry regulations is preferred
  • Experience using Microsoft Office and other computer based applications (I pad, One Note, etc.)
  • Excellent people skills, maintain a positive attitude and ability to motivate people, specifically mentoring and coaching individuals
  • Ability to communicate effectively, both orally and written
  • Must be able read, interpret and comprehend weights, measurements, and mathematical equations
  • Be able to effectively understand and adhere to a variety of guidelines and work procedures (including health, safety, hygiene and sanitation), along with prioritizing and organizing workload
  • Ability to learn quickly and work both independently and as a team
  • Ability to work in a fast-paced, challenging, and consistently changing environment
Job Responsibility
Job Responsibility
  • Inspect the day-to-day quality and food safety activities
  • Effectively communicate quality control expectations to production personnel
  • Monitor GMP’s for compliance
  • Ensure that employees adhere to manufacturing, hygiene and sanitation standards
  • Conduct start-up and in-process checks to ensure the manufacturing process is conforming to customer specifications. This includes verification for correct product, correct formulation, documentation of ingredient lot numbers, correct code date / best by date etc.
  • May perform pre-operation inspection at the start of the production shift as well as pre- sanitation inspection at the end of the shift
  • Validate production pre-operational sheets are complete and accurate
  • Conduct metal detector and X-ray checks and monitoring through the course of the shift
  • Conduct sensory evaluations of raw materials and finished product, ensure specification compliance for finished products
  • Calibration of all scales and other laboratory equipment
What we offer
What we offer
  • Working in a family business on a human scale
  • Evolving in a clean, temperate environment with the latest technology
  • Embracing high velocity production and cutting edge technology
  • Starting a new job with paid and adapted training
  • Earning a competitive salary
  • Benefiting from a complete benefits program (drug and dental insurance, 1 week of sick leave [conditions apply], telemedicine, group RRSP with employer participation and more)
  • Saving on our delicious products and discovering exclusive novelties
  • Taking advantage of job security and opportunities for advancement within the company
  • Integrating a rich company culture (Christmas, birthday and maternity gifts, use of the Poka platform and more)
  • Fulltime
Read More
Arrow Right

Quality Control Technician

The Quality Control Technician reports to the Quality Manager. S/he is responsib...
Location
Location
United States , Cornwall
Salary
Salary:
Not provided
leclerc.ca Logo
Biscuits Leclerc Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associates degree in Food Science and Technology, Biology, or equivalent combination of education/experience
  • Minimum of 2 years’ experience in technical field (engineering, food science, chemistry) with industry experience
  • Knowledge of GFSI / BRC, SQF, GMP and other food safety standard including HACCP or similar food industry regulations is preferred
  • Experience using Microsoft Office and other computer based applications (I pad, One Note, etc.)
  • Excellent people skills, maintain a positive attitude and ability to motivate people, specifically mentoring and coaching individuals
  • Ability to communicate effectively, both orally and written
  • Must be able read, interpret and comprehend weights, measurements, and mathematical equations
  • Be able to effectively understand and adhere to a variety of guidelines and work procedures (including health, safety, hygiene and sanitation), along with prioritizing and organizing workload
  • Ability to learn quickly and work both independently and as a team
  • Ability to work in a fast-paced, challenging, and consistently changing environment
Job Responsibility
Job Responsibility
  • Inspect the day-to-day quality and food safety activities
  • Effectively communicate quality control expectations to production personnel
  • Monitor GMP’s for compliance
  • Ensure that employees adhere to manufacturing, hygiene and sanitation standards
  • Conduct start-up and in-process checks to ensure the manufacturing process is conforming to customer specifications. This includes verification for correct product, correct formulation, documentation of ingredient lot numbers, correct code date / best by date etc.
  • May perform pre-operation inspection at the start of the production shift as well as pre- sanitation inspection at the end of the shift
  • Validate production pre-operational sheets are complete and accurate
  • Conduct metal detector and X-ray checks and monitoring through the course of the shift
  • Conduct sensory evaluations of raw materials and finished product, ensure specification compliance for finished products
  • Calibration of all scales and other laboratory equipment
What we offer
What we offer
  • Working in a family business
  • Evolving in a clean, temperate environment with the latest technology
  • Starting a new job with paid and adapted training
  • Benefit from a complete benefits program (drug and dental insurance, 1 week of sick leave [conditions apply], telemedicine, group RRSP with employer participation and more)
  • Save on our delicious products and discover exclusive novelties
  • Take advantage of job security and opportunities for advancement within the company
  • Integrate a rich company culture (Christmas, birthday and maternity gifts, use of the Poka platform and more)
  • Fulltime
Read More
Arrow Right

Analytical Lab Manager

Maintain efficient operation as well as perform environmental monitoring, bacter...
Location
Location
Salary
Salary:
Not provided
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in laboratory technology, Microbiology, Biotechnology, Chemistry or related field
  • Advanced English level
  • Previous experience in microbiological testing, environmental monitoring or endotoxin testing (preferably within the medical device industry)
  • Knowledge of regulatory standards: ISO 13485 and FDA 21 CFR Part 820
  • Ability to follow standard operating procedures and interpret technical documents
  • Advanced knowledge of MS Office tools (Excel, Word and lab software)
Job Responsibility
Job Responsibility
  • Responsible to coordinate all environmental control activities for the facility, including certifications, and the periodic review of environmental monitoring results, as well as any tasks related environmental impact, change control and biological tests
  • Responsible to perform and maintenance the Biocontamination assessments for the product families
  • Ensure compliance with Standard Operating Procedures (SOPs)
  • Maintain required environmental and control conditions
  • Manage inventory of reagents, consumables, and equipment
  • Schedule and coordinate test execution
  • Supervise, train, and evaluate laboratory technical staff
  • Promote continuous training and a culture of compliance
  • Review and approve test records and reports
  • Investigate deviations or out-of-specification (OOS) results
Read More
Arrow Right

Sr. Fsqa Manager

Lead the manufacturing facility Food Safety & Quality Assurance department and c...
Location
Location
United States , Oakland
Salary
Salary:
Not provided
ajinomotofoods.com Logo
Ajinomoto Foods North America, Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS degree in Food Science, Microbiology, Biology or equivalent is required
  • 10+ years Quality Control/Quality Assurance experience in USDA food manufacturing environment with at least half of the experience being in a supervisory capacity is required
  • Frozen food experience preferred, but not mandatory
  • Certifications through ASQC, SQF, GFSI and other professional quality associations are helpful
  • Budget/Cost Control – general understanding of QA/procurement budgeting and cost control functions
  • Presentation Skills – ability to make clear, concise and convincing business presentations
  • Analytical – ability to independently perform, mentor and manage others in conducting complex technical analysis of manufacturing data, statistical process control (SPC) and supplier performance
  • Leadership – ability to act as team leader for special task assignments
  • Mentoring – ability to mentor other QA team members in technical knowledge and QA management skills
  • Communication Skills – excellent verbal and written communication skills, including technical writing and presentation skills
Job Responsibility
Job Responsibility
  • Lead the manufacturing facility Food Safety & Quality Assurance department and carry out management responsibilities in accordance with Ajinomoto policies, procedures and applicable regulatory laws
  • Lead all regulatory compliance requirements
  • training and managing associates
  • establishing audit-ready procedures for the facility
  • record-keeping
  • laboratory management
  • maintaining quality, food safety and sanitation parameters of AWI products and facilities
  • have an understanding of labeling, exports and RTE and NRTE food manufacturing and sanitation processes
  • Fully implement and manage all AWI FSQA policies and procedures regarding food safety and quality
  • Develop, implement and manage new and on-going quality assurance and food safety training programs at the facility
  • Fulltime
Read More
Arrow Right

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in scientific discipline
  • Advanced degree preferred
  • Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
  • Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
  • Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
  • Experience interacting with external testing laboratories preferred
  • Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
  • Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
  • Strong team orientation and passion for continuous self-development
  • Experience in industry or in a startup industrial setting is preferred
Job Responsibility
Job Responsibility
  • GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
  • Batch Review / Release: Perform full batch record review of all types of investigations
  • perform appropriate quality control review of all QC data generated by third parties
  • draft, review, and approve CoA (internal/external)
  • Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
  • Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
  • Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
  • Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
  • Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
  • Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right

Lab Supervisor - Microbiology

Are you an experienced clinical laboratory professional looking for leadership o...
Location
Location
United States of America , Tampa
Salary
Salary:
Not provided
labcorp.com Logo
Labcorp
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate’s degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or a non-traditional Associate’s degree that meets local regulatory
  • Minimum 5 years of experience as a Technologist/Technician
  • FL State Clinical Laboratory Supervisor license required
  • Strong working knowledge of CLIA, CAP and relevant state regulations
  • Understanding of laboratory operations as well as policies and procedures
  • Proficient with Laboratory Information Systems and Microsoft Office
  • Strong communication skills
  • both written and verbal
  • High level of attention to detail with strong organizational skills
  • Comfortability making decisions in a changing environment
Job Responsibility
Job Responsibility
  • Supervise the day to day operations of the Microbiology department
  • Ensure laboratory tests are accurately performed and results are reported in a timely manner
  • Directly supervise, train, and mentor laboratory personnel of the department
  • Monitor daily workflow in the lab and schedule adequate assay coverage
  • Responsible for ensuring all shifts in the department are properly staffed
  • Research and resolve any production errors while escalating when necessary
  • Engage in continuous process and service level improvements
  • Ensure all equipment is being properly maintained through Quality Control
  • Prepare and maintain Quality Assurance records and documents
  • Evaluate new process improvements and make appropriate recommendations
What we offer
What we offer
  • $10,000 sign on bonus
  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD
  • 401(k)
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy