Intern, Quality Control, Microbiology Job at BioMarin Pharmaceutical (Novato)

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

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

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

health and retirement
PTO
stock option plans

Analytical Lab Manager

Maintain efficient operation as well as perform environmental monitoring, bacter...

Location

Salary:

Not provided

Avanos

Expiration Date

Until further notice

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

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

Quality Technician

Maternity Cover 12 - 18 months. Conduct daily quality activities related to samp...

Location

United Kingdom , Kent

Salary:

28000.00 - 30000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

Understanding of Quality/Technical requirements and standards of the food industry: GFSI or similar
Minimum of 2 years’ experience in a Quality, Technical or similar role in food/supplement manufacturing/ distribution
Some experience in resolving non-conformances or complaints is beneficial
Awareness of microbiological processes and procedures is an advantage, but not essential

Job Responsibility

Conduct daily quality activities related to sampling, testing, reporting, and releasing finished products and raw materials
Carry out some of the site pre-requisite controls (Allergens monitoring, Environmental monitoring, temperature and humidity records, pest control)
Provide day-to-day support to the quality department in the area of document control, supplier approval and monitoring admin tasks, internal auditing (hygiene, glass, plastic etc.)
Flag any analytical failures (OOS results) to the rest of the operational team and support failure investigations
Coordinate concession, pre-shipment samples and urgent orders with the customer support team
Conduct GMP, hygiene Audits, and environmental and allergen swabs in production
Support validation activities (allergen, homogeneity, cleaning, shelf-life)
Carry out some of the site's pre-requisite controls, such as temperature and humidity records
Verifying batch documents and labels before releasing them to production for manufacture
Collating analysis results and positively releasing the finished product

What we offer

Personal growth, including training and development opportunities
Health Cash Plan
Subsidised gym membership
Discretionary bonus

Fulltime

Laboratory Technician

Do you have a keen interest in Science and looking to work in an accredited labo...

Location

United Kingdom , Hereford

Salary:

24444.42 - 25900.88 GBP / Year

Avara Foods

Expiration Date

Until further notice

Requirements

Education to A level (or equivalent) in Biology or other relevant scientific subject or relevant experience
Experience of laboratory testing in a food laboratory
Strong attention to detail
Competent IT Skills

Job Responsibility

Undertaking routine laboratory work and performing analysis to CLAS / RSA, UKAS and DEFRA standards
Using the Laboratory Information Management System (LIMS) in accordance with the procedures
Liaising with internal and external customers, dealing with their requests and queries
Carrying out environmental controls, QA controls and ensuring adherence to the task rota
Participating in the EQA / IQA proficiency schemes

What we offer

31 Days Holiday
3% Pension
Life Insurance
Various lifestyle benefits, including wellbeing resources
Comprehensive training
Continuous development

Fulltime

Senior QA Executive 1

You will play a key role in ensuring quality and compliance in a modern manufact...

Location

Singapore , Tuas

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science, microbiology, biotechnology, pharmacy, engineering, or a related discipline
At least 6 years of experience in quality assurance within the pharmaceutical or biologics industry
Strong knowledge of GMP and regulatory requirements relevant to manufacturing and quality
Practical experience with deviations and CAPA processes
Experience with validation, qualification and change control practices
Good written and verbal communication skills in English

Job Responsibility

Provide QA oversight - Sterility Assurance for site manufacturing processes and products manufactured by the site
Provide QA oversight – Quality control laboratory for Microbiology and Endotoxin tests
Develop, implement, and monitor sterility assurance programme on site
Lead sterility assurance activities: sterile process oversight, container closure integrity (CCI) strategies, aseptic process simulation (media fills), and bioburden or sterility-related investigations
Develop, review and approve microbiology and sterility-related SOPs, specifications, and test methods
ensure documentation is current and GxP-compliant
Provide technical direction for microbiology method development, transfer, validation, troubleshooting, root cause analysis, and corrective/preventive actions (CAPA)
Manage deviations, OOS/OOT events and non-conformances related to microbiology and sterility
lead investigations and ensure timely regulatory-compliant reporting
Establish and maintain environmental monitoring programmes

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Manager Infection Prevention - Infection Control

In a High Reliability Organization, Manager Infection Prevention is responsible ...

Location

United States , Corpus Christi

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

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

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

Specialist, Quality Control Microbiology

Lead the Environmental Monitoring and Utilities Monitoring programs to support t...

Location

United States , Holly Springs

Salary:

106929.00 - 132709.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 10 years of Quality or Aseptic Manufacturing experience
Associate’s degree and 8 years of Quality or Aseptic Manufacturing experience
Bachelor’s degree and 4 years of Quality or Aseptic Manufacturing experience
Master’s degree and 2 years of Quality or Aseptic Manufacturing experience
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 regulatory inspections
Strong knowledge of aseptic technique

Job Responsibility

Provide site-level leadership and strategic ownership of the Environmental Monitoring (EM) and Utilities Monitoring programs, ensuring sustained compliance, data integrity, and a proactive state of control across manufacturing operations
Serve as the primary subject matter expert (SME) for environmental monitoring, utilities monitoring, and contamination control, providing expert guidance to site leadership, cross-functional partners, and global stakeholders
Establish, oversee, and continuously improve monitoring strategies, including data review, trend analysis, interpretation and presentation to support risk-based decision making
Author, review, and approve GMP documentation and technical deliverables, including SOPs, safety assessments, trend reports, qualification and validation summary reports, microorganism assessments, and other technical reports
Lead the planning and execution of Environmental Monitoring Performance Qualification (EMPQ) activities in support of facility changes, expansions, and new initiatives, partnering closely with QC Micro Sampling and Testing teams
Provide technical oversight and governance for Clean Utilities qualification activities, ensuring alignment with regulatory expectations and internal quality standards
Drive cross-functional alignment with Manufacturing, Facilities & Engineering, Quality, and other stakeholders to ensure monitoring programs support both compliance and business objectives
Drive the site Contamination Control Strategy, participating in contamination risk assessments and ensuring effective implementation, monitoring, and continuous improvement in alignment with global standards
Represent the site in global environmental monitoring and contamination control forums, influencing best practices, sharing expertise, and driving harmonization across the network
Deliver clear, data-driven communication to site leadership, including routine presentations on environmental and utilities monitoring performance, risks, trends, and mitigation strategies

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
Flexible work models where possible

Fulltime

Manager, Quality Control

This position is responsible for the daily QC oversight of PCI’s laboratory func...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred
5+ years of Pharmaceutical or Biotechnology industry experience
Experience in leading a commercial, aseptic drug product quality control team
5+ years previous QC management experience
Quality leadership experience working on cross-functional teams to harmonize operational, testing and compliance processes
Experience in the Management of +5 people

Job Responsibility

Provides Quality Control oversight of all cGMP testing of raw materials, in process, product release, clean utility and environmental monitoring testing
Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories
Maintains good relations and communications with clients as a primary technical interface
Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel
Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes
Leading customer interaction on all QC related projects including routine testing updates
Manage and develop professional and technical skills and performance of department members
Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary
Supporting regulatory information requests from customers as it pertains to QC

Fulltime

Intern, Quality Control, Microbiology

BioMarin Pharmaceutical

Location:
United States , Novato

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 16, 2026

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Job Posted:January 16, 2026

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