Manager, Quality Control Microbiology Job at Amgen (Holly Springs)

Associate Quality Control (Microbiology)

Amgen is one of the world’s leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience
Associate’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 4 years of directly related experience
Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience
At least 1-3 years of relevant professional work experience within the biopharmaceutical industry and QC laboratory experience preferred
Possess sound knowledge and understanding of GMP pharmaceutical operations and associated QC testing methods, inclusive of GMP laboratory operation
Experience with Quality Control testing and laboratory operations for common microbial testing methods and equipment (e.g. including but not limited to bioburden, endotoxin, microbial identification, environmental monitoring, microbial limits, growth promotion, biological indicators)
Able to interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Possess problem solving skills with the ability to apply logic and assess data to troubleshoot and reach decisions or solutions related to assay
Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Job Responsibility

Execute testing and/or review for routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, qPCR, microbial ID etc.)
media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, microorganisms culture types etc.)
Sample management such as sample logging, movement, storage of samples, reconciliation of sample receipt, aliquoting samples, management of stability samples, and sample shipment to Amgen network sites and/or contract labs
Involvement in document revisions and report writing
Involvement in method transfers, method validation/verification and sample type qualification
Laboratory housekeeping and document archival
Project management / Involvement in QC projects (e.g. Continuous Improvement/ Operational Excellence)
When required, able to support 12-hour rotating day shift (8am - 8pm), inclusive of weekends and public holidays

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Associate Quality Control (Microbiology)

Associate Quality Control (Microbiology) Amgen Singapore Manufacturing HOW MIG...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience
Associate’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 4 years of directly related experience
Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience
Have at least 1-3 years of relevant professional work experience within the biopharmaceutical industry and QC laboratory experience preferred
Possess sound knowledge and understanding of GMP pharmaceutical operations and associated QC testing methods, inclusive of GMP laboratory operation
Experience with Quality Control testing and laboratory operations for common microbial testing methods and equipment (e.g. including but not limited to bioburden, endotoxin, microbial identification, environmental monitoring, microbial limits, growth promotion, biological indicators)
Able to interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Possess problem solving skills with the ability to apply logic and assess data to troubleshoot and reach decisions or solutions related to assay

Job Responsibility

Execute testing and/or review for routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, qPCR, microbial ID etc.)
media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, microorganisms culture types etc.)
Sample management such as sample logging, movement, storage of samples, reconciliation of sample receipt, aliquoting samples, management of stability samples, and sample shipment to Amgen network sites and/or contract labs
Involvement in document revisions and report writing
Involvement in method transfers, method validation/verification and sample type qualification
Laboratory housekeeping and document archival
Project management / Involvement in QC projects (e.g. Continuous Improvement/ Operational Excellence)
When required, able to support 12-hour rotating day shift (8am - 8pm), inclusive of weekends and public holidays
All listed tasks and responsibilities are deemed as essential functions to this position
however, business conditions may require reasonable accommodation for additional tasks and responsibilities

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
The ability to manage and supervise a team of employees
Proven leadership skills with the ability to effectively manage, engage and develop teams
Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
Strong change leadership capabilities and experience supporting enterprise-level initiatives

Job Responsibility

Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
Serve as a primary quality microbiology liaison during regulatory inspections
lead preparation activities and develop effective, timely responses to regulatory observations
Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
promote a strong safety culture

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Sr Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
The ability to manage and supervise a team of employees
Proven leadership skills with the ability to effectively manage, engage and develop teams
Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
Strong change leadership capabilities and experience supporting enterprise-level initiatives

Job Responsibility

Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
Serve as a primary quality microbiology liaison during regulatory inspections
lead preparation activities and develop effective, timely responses to regulatory observations
Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
promote a strong safety culture

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Associate Quality Control Microbiology

In this vital role, you will be responsible for analytical testing, sample and d...

Location

United States of America , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

High school / GED + 2 years of quality control work experience
Associate's + 6 months of quality control work experience
Bachelor's degree
Degree in Microbiology with +2 years of quality control experience
GMP laboratory experience in the Pharmaceutical or Biotech industry
Availability to the third shift including rotative weekdays and weekends
Knowledge of regulatory compliance, safety protocols, and GMP standards
Strong attention to detail, with solid organizational and time management skills
Bilingual in Spanish and English
effective in technical writing and communication

Job Responsibility

Perform routine and non-routine laboratory procedures, including aseptic aliquoting and analysis for both compendial and non-compendial methods
Conduct or support activities such as sample testing, standards and reagent preparation, environmental monitoring, sample management, and equipment maintenance
Ensure accurate, complete, and timely documentation of laboratory work, and participate in document revisions as needed
Review, analyze, and communicate test results
may participate in investigations, audits, or approve laboratory results as applicable
Complete all work in compliance with established procedures and scientific/technical standards

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
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 and an annual site shutdown
Flexible work models where possible

Fulltime

Analyst II, Quality Control Microbiology

The incumbent will support the implementation and execution of core microbiology...

Location

United States , Durham

Salary:

70000.00 - 115000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a scientific discipline
2+ years' relevant experience in the pharmaceutical/biotech industry
Excellent verbal and written communication skills
Strong writing skills
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work equally well individually as within a multi-disciplinary team
Excellent time management skills
Consistent delivery of high-quality work at all times

Job Responsibility

Draft documentation for the microbiology programs (SOPs, WIs, Protocols, reports etc.)
Conduct and draft investigations for the microbiology programs (EM excursions, lab deviations, product OOS's, etc.)
Support the implementation and execution of microbiology laboratory programs, including bioburden, endotoxin, and rapid sterility testing, method verifications, media growth promotion and gram staining
Support the implementation and execution of the environmental monitoring (EM) program
Review and approve laboratory data for the microbiology programs
Support the incoming testing and management of raw materials
Assist with the data analysis and trending program for EM data
Support the implementation of the disinfectant efficacy qualification program
Partner with CQV representative to support the implementation of QC lab equipment by providing technical assistance during the development and execution of IQ/OQ/PQ protocols
Provide assistance for the implementation of the site LIMS

Fulltime