QC Specialist - Microbiology Job at SRG (Speke, Liverpool)

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

Specialist, Quality Control

The Quality Management Associate Scientist (QMAS) performs microbiological tests...

Location

United States , Hunt Valley

Salary:

Not provided

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Experience in microbiological testing and techniques
Experience in operating stationary laboratory instruments
Experience in working with computer systems and software in a laboratory setting
Proficiency in standard microbiology laboratory techniques, including pipetting, inoculations, and serial dilutions
Strong aseptic technique
Detail-oriented and organized
Good time management skills
Ability to work effectively in a team setting as well as independently
Ability to operate low to moderate complexity stationary instruments (e.g., pH meters, analytical balances, spectrophotometers)
Ability to maintain handwritten records accurately

Job Responsibility

Perform microbiological tests using techniques such as pipetting, streak/spread plate inoculations, pour plate methods, serial dilutions, and stab inoculation
Conduct visual inspections of physical samples and review paper records
Operate stationary instruments such as pH meters, analytical balances, and spectrophotometers
Maintain aseptic technique and ensure detailed, organized work
Perform non-routine tasks, including supporting product inspections and investigations
Work with computer systems and software regularly
May perform testing of Mycobacterium tuberculosis (TB) and similar organisms in a Biosafety Level 3 Laboratory, adhering to strict safety policies
Use personal protective equipment (lab coats, respirator masks, gloves, non-permeable full cover shoes, and safety glasses) for extended periods
Work in various laboratories within the QC department without a permanent assignment

Fulltime

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis
Conduct the required testing, incubation and plate reading of these samples
Perform daily solution bioburden testing for total count and spore count
Perform processing of biological indicators to support sterilizer qualifications
Perform daily endotoxin and subvisible particulate testing of finished goods

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program
Conduct the required testing, incubation and plate reading of these samples in accordance with specifications
Perform daily solution bioburden testing for total count and spore count in accordance with approved procedures
Conduct testing of raw materials as required
Perform processing of biological indicators to support sterilizer qualifications

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years experience
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis
Conduct the required testing, incubation and plate reading of these samples in accordance with specifications
Perform daily solution bioburden testing for total count and spore count
Conduct testing of raw materials as required
Perform processing of biological indicators to support sterilizer qualifications

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Microbiology
Quality Assurance
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization.

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing.
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program.
Sample and test the critical systems like compressed air and water.
Process the biological indicators associated with sterilizer qualifications.
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc.
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis.
Conduct the required testing, incubation and plate reading of these samples in accordance with specifications.
Perform daily solution bioburden testing for total count and spore count.
Conduct testing of raw materials as required.
Perform processing of biological indicators to support sterilizer qualifications

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Microbiologist

As a Quality Control Microbiologist, you are a key part of a fast-paced environm...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0-2 years experience
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program
Conduct the required testing, incubation and plate reading of these samples in accordance with specifications
Perform daily solution bioburden testing for total count and spore count in accordance with approved procedures ensuring required documentation is complete and all results are read in a timely manner
Conduct testing of raw materials as required
Perform processing of biological indicators to support sterilizer qualifications

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Specialist Quality Control

In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Industry related Microbiology and Environmental Monitoring experience
Quality Control laboratory experience
Degree in Microbiology or other Life Science
High school diploma / GED and 12 years of related experience
Associate’s degree and 10 years of related experience
Bachelor’s degree and 8 years of related experience
Master’s degree and 6 years of related experience
Doctorate degree and 2 years of related experience
Strong technical writing skills within a highly regulated environment
Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control

Job Responsibility

Managing document requests from the global QC Network, including intake, prioritization, and tracking to completion
Creating, authoring, revising, and coordinating workflows for a variety of controlled document types, ensuring completion within agreed timelines and in compliance with procedural requirements
Collecting, organizing, and analyzing data from multiple repositories (e.g., LIMS, electronic laboratory notebooks) to support document management activities
Facilitating information gathering and alignment across the QC Network and cross-functional partners to support document updates and process harmonization
Driving project deliverables to ensure timely and high-quality completion of assigned tasks and initiatives
Supporting issue identification and resolution, collaborating effectively across sites and functions to maintain operational continuity
Ensuring all controlled documents meet Amgen’s quality standards and comply with cGMP, safety, and other applicable regulatory requirements
Ensuring all assigned training requirements are completed, current, and compliant with cGMP standards
Identifying opportunities for continuous improvement to ensure alignment in document structure, formatting standards, and data retrieval/compilation practices across the network

QC Specialist - Microbiology

SRG

Location:
United Kingdom , Speke, Liverpool

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 20, 2026

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