1,759 Qc Microbiology Analyst jobs in the United States

QC Microbiology, Analyst

Westborough, Massachusetts Planet Pharma

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null

Pay Range $31 - $33.78 per hr. - Medical, Dental, Vision, 401K


The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.


Essential Job Responsibilities:

Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.

Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.

Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.

Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.

Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.

Author/update laboratory procedures, protocols, and help in EM data trend reports.

Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.

Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.

Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.


Required:

B.S. degree in Biology/ or other life science related degree with 0-3 years of relevant industry experience in a quality control role. While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience.

Excellent knowledge of Aseptic technique and common microbiological testing

Knowledge of relevant, compliance and guidance documents

Must be able to gown into cleanrooms in support of testing and manufacturing activities

Good documentation (ALCOA +) and data organization

Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.Interpersonal skills and ability to contribute to the success of a team


Preferred:

Proven history of working in a fast-paced team environment, time management, and meet deadlines.

Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed

Models our Core Values: Bold, Caring, and Results-Driven — consistently exemplifies the culture we strive to create, operates with transparency, and earns trust.

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QC Analyst

01701 Framingham, Massachusetts Sanofi Group

Posted 3 days ago

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**Job Title:** QC Analyst (Microbiology)
**Location:** Framingham, MA
**Shift:**
**Sun-Wed 12:00 pm - 10:30 pm**
**Wed - Sat 12:00 pm - 10:30 pm**
**About the Job**
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
The Quality Control team is dedicated to the development and validation of
methodologies using state-of-the-art technology and responsible for ensuring that all production lots and materials meet the required quality standards, supporting regulatory compliance, and operational excellence of the organization.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
+ Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
+ Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
+ Recording all expected raw data, calculations, information related to his/her tasks, to comply with cGMP and data integrity requirements
+ Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
+ Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
+ Informing his/her manager of any quality or HSE event (deviations, OOS,) in a timely manner to ensure investigation and impact assessment are performed appropriately
+ Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
+ Executing assigned CAPAs related to remediation plans, continuous improvements
+ Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
**Additional Accountabilities:**
Ability to perform tasks in a Quality Control Laboratory environment and capable of lifting at least 10 pounds. May be required to pass vision exam to perform specific responsibilities. May be required to enter into controlled environments following proper gowning protocols
**About You**
**Basic Qualifications:**
+ High School Diploma with a minimum of 4 Years of relevant industry experience.
+ Associate Degree with 2-4 Years of relevant industry experience.
+ Bachelor's Degree with 0-2 Years of relevant industry experience.
+ Proficient with Microsoft Office tools such as Word, Excel & PowerPoint.
**Preferred Qualifications:**
+ 1 Year of Experience in a GMP lab environment.
+ Proficiency in Microsoft Office tools such as: Word, Excel & PowerPoint.
+ Experience with lab-based data management systems.
+ Experience in a Quality Control Laboratory.
+ Experience with Environmental Monitoring, including Water Testing.
**Special Working Conditions:**
+ Work in a laboratory with minimal use of chemicals.
+ Ability to lift 10 lbs.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
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**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$26.32 - $35.09
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK ( .
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
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QC Analyst

44202 Aurora, Ohio Astrix Technology

Posted 11 days ago

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Job Description

**QC Analyst**
Laboratory
Aurora, OH, US
Pay Rate Low: 22.00 | Pay Rate High: 22.00
+ Added - 15/04/2025
Apply for Job
**Quality Control Analyst**
**Location:** Aurora, Ohio
**Schedule:** 2nd shift Mon-Friday, 3pm-11:30pm 22/hr.
**Job Summary:**
The Quality Control Analyst is responsible for performing chemical and microbiological testing on raw materials, in-process samples, and finished products in accordance with established specifications and regulatory standards. This role involves operating laboratory equipment, documenting results in LIMS, conducting environmental monitoring, and ensuring compliance with GMP and safety protocols.
**Key Responsibilities:**
+ Perform routine and non-routine analysis using techniques such as pH, UV, FTIR, KF, titrations, and microbiological assays (e.g., bioburden, endotoxin).
+ Interpret and document results, ensuring compliance with USP, EP, BP, JP, and internal standards.
+ Calibrate and maintain laboratory instruments.
+ Conduct environmental monitoring and cleanroom sampling.
+ Support investigations, data verification, and lab documentation updates.
**Qualifications:**
+ Bachelor's degree in Chemistry, Biology, Microbiology, or related field.
+ 1-3 years of QC lab experience; wet chemistry and microbiological testing preferred.
+ Strong analytical, problem-solving, and communication skills.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Senior QC Analyst

93012 Camarillo, California Astrix

Posted today

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Our client, a global CDMO, offering products and services across the drug development spectrum is looking for a skilled Sr. QC Analyst to join their team in Camarillo, CA!


Job Title: Senior QC Analyst

Location: Camarillo, CA

Pay rate: $37 - $39/ hr.


Job Summary:

We are seeking a highly skilled and detail-oriented Senior QC Analyst to perform complex analytical testing in support of pharmaceutical product development and manufacturing. The ideal candidate will have advanced experience in chromatography techniques (e.g., HPLC, UPLC, GC), method validation, data analysis, and regulatory compliance. This position plays a critical role in ensuring product quality, supporting investigations, and driving continuous improvement across the QC function.


Key Responsibilities:

  • Perform complex analytical testing including Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), and other instrumental and wet chemistry techniques.
  • Troubleshoot analytical instruments and resolve method or equipment-related issues.
  • Participate in and assist with test method validations, verifications, and transfers.
  • Evaluate and analyze test data to identify trends, outliers, or potential issues.
  • Support OOS (Out of Specification) and OOT (Out of Trend) investigations, including CAPA (Corrective and Preventive Action) documentation.
  • Coordinate testing activities with external laboratories, including raw material and specialized testing.
  • Execute, author, and review SOPs, test methods, protocols, reports, investigations, change controls, and data summaries.
  • Utilize risk assessment and root cause analysis tools (e.g., 5 Whys, Fishbone) to support investigations and process improvements.
  • Manage aspects of the stability program, including scheduling, testing, and reporting, and investigate aberrant stability results.


Qualifications:

  • Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
  • 3–6+ years of relevant experience in a regulated laboratory environment (pharmaceutical, biotech, or similar).
  • Strong technical expertise in HPLC, UPLC, GC, and other analytical techniques.
  • Working knowledge of cGMP regulations, ICH guidelines, and regulatory expectations.
  • Experience with method validation and stability programs preferred.
  • Ability to manage multiple tasks and work independently in a fast-paced environment.
  • Experience with electronic data systems (e.g., Empower, LIMS, TrackWise, MasterControl).


Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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QC Analyst II

92058 San Luis Rey, California Consultant Specialists, Inc. (CSI)

Posted today

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Job Description

The Opportunity


Conduct quality control testing on products and materials

Analyze test results and report deviations

Ensure compliance with GMP and regulatory standards

Document quality control procedures and findings

Assist in troubleshooting and root cause analysis


Who You Are


• 5–10 years of experience, specifically BioAssay or Cell Culture required

• Strong problem-solving skills

• Excellent communication abilities

• Knowledge of industry best practices


Preferred


Experience with laboratory GMP testing required

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QA/QC Analyst

01035 Hadley, Massachusetts Actalent

Posted 4 days ago

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Job Description

Job Title: QA/QC Analyst
Job Description
We are seeking a highly motivated and proactive QA/QC Analyst to ensure quality assurance and quality control of our products. This role involves tracking and fulfilling customer documentation requests, drafting and issuing required QA statements, and maintaining correct documentation standards. The position also requires reviewing certificates of analysis (COAs) for raw materials and finished ingredients to align with specifications and managing sample submissions through external labs.
Responsibilities
+ Track and fulfill customer documentation requests.
+ Draft and issue required QA statements.
+ Review and ensure correct version, signatory, and date are maintained.
+ Draft and/or review COAs for raw materials and finished ingredients to ensure alignment against specifications.
+ Create and update items in TraceGains.
+ Support completion of customer questionnaires.
+ Manage sample submissions through external labs.
Additional Skills & Qualifications
+ 3-5 years of QA experience in food or dietary supplement manufacturing/supply.
+ Working knowledge of 21 CFR 111/117.
+ PCQI trained.
+ Hands-on experience with TraceGains.
+ Ability to work autonomously.
+ Strong written communication and documentation practices.
Work Environment
This is a fully remote role with working hours from Monday to Friday, 8 am to 5 pm, with some flexibility. The role requires a self-motivated individual who can work independently in a remote setting.
Pay and Benefits
The pay range for this position is $25.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Oct 14, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Qa/qc Analyst

01035 Hadley, Massachusetts Actalent

Posted 4 days ago

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Job Description

Description
- Track and fulfill customer documentation requests - Draft/issue required QA statements - Review and ensure correct version, signatory, date, etc. are maintained - Draft and/or review COAs for raw materials and finished ingredients to ensure alignment against specifications - Create/update items in TraceGains - Support completion of customer questionnaires - Manage sample submissions through external labs
Skills
Quality assurance, Regulatory, Adverse event reporting, Clinical documentation, Quality assurance testing, Gmp
Top Skills Details
Quality assurance,Regulatory,Adverse event reporting,Clinical documentation
Additional Skills & Qualifications
- 3-5 years of QA experience in food or dietary supplement manufacturing/supply - Working knowledge of 21 CFR 111/117 - PCQI trained - Hands-on experience with TraceGains - Ability to work autonomously and efficiently - Strong written communication and documentation practices
Experience Level
Intermediate Level
Pay and Benefits
The pay range for this position is $25.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Oct 10, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Service QC Analyst

33126 Flagami, Florida Danaher Corporation

Posted 14 days ago

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Job Description

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System ( which makes everything possible.
The Service QC Analyst is responsible for leading the evaluation of record activities and findings as part of an ongoing global field service quality control process. This includes driving prioritization, management and participation in projects that are related to the customer facing global service and support enablement and use of tools and process.
This position reports to the Senior Manager of Global Service Compliance and Technical Publications and is part of the Service Organization located at Miami, FL site. This will be an on-site role.
In this role, you will have the opportunity to:
+ Evaluate documentation of service records against expected standard across a complex product portfolio and provide insight as to what trends are impacting the business, utilizing analytics with trending of failures including recommendations for improvement.
+ Technical awareness and knowledge to facilitate informed evaluation of technical steps taken as evidenced within the service records being reviewed.
+ Gather, organize, and provide comprehensive documentation and evidence requested by auditors in a timely and accurate manner.
+ Stay informed about relevant regulatory requirements, industry standards, and internal policies that impact service operations.
The essential requirements of the job include:
+ Bachelor's degree in closely related field with multiple years of experience
+ Advanced knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software.
+ Effective communicator - excellent verbal, written and oral presentation skills are a must. Must have the ability to adapt to different audiences. Communicates complex information accurately with internal and external contacts.
+ Documentation Expertise - skill in gathering, organizing, verifying, and presenting comprehensive documentation and evidence to auditors in a structured and timely manner.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - 10 % travel to support audits or for team meetings.
It would be a plus if you also possess previous experience in:
+ Knowledge of relevant internal policies, industry standards, and regulatory frameworks (e.g., SOX, HIPAA, GDPR, ISO standards, etc.) applicable to the records and operations being audited.
+ Organizational Skills - strong ability to manage multiple audit requests, deadlines, and documentation requirements concurrently.
+ Exceptional Attention to Detail - critical for accurately auditing records and ensuring that information provided to auditors is precise and complete.
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide.
#LI-GC1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .
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QC Analyst II

60684 Chicago, Illinois Astrix Technology

Posted 17 days ago

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Job Description

**QC Analyst II**
Manufacturing
Chicago, IL, US
Pay Rate Low: 30 | Pay Rate High: 33.65
+ Added - 14/04/2025
Apply for Job
Our client, a global leader in biopharma R&D and manufacturing, is seeking an experienced **QC Analyst II** to support upstream/downstream manufacturing operations.
**QC Analyst II**
+ **Pay** : $29-33/hr
+ **Hours:** 1st shift M-F
+ **Terms:** 6 month contract-to-hire
**Key Responsibilities:**
+ Perform analytical testing for in-process, release, and stability studies.
+ Support OOS investigations, deviations, CAPAs, and audits.
+ Collaborate with cross-functional teams on projects and equipment maintenance.
+ Author and revise SOPs, QC methods, and reports.
+ Train junior analysts and support regulatory inspection readiness.
**Qualifications:**
+ BS in biotech, biochem, or related field + 5 yrs QC lab exp.(MS + 3 yrs or PhD + 2 yrs also considered)
+ cGMP lab experience required.
+ Strong background in protein chemistry and analytical troubleshooting.
**Technical Skills:**
+ Proficient with HPLC, SDS-PAGE, ELISA, CE, bioassays, and compendial methods.
+ Experience with regulatory filings and inspection prep (e.g., PAI).
**Additional Info:**
+ Office/lab split; some travel may be required.
+ Fast-paced environment; must meet tight deadlines.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Senior QC Analyst

93010 Camarillo, California Astrix Technology

Posted 17 days ago

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Job Description

**Senior QC Analyst**
Quality Assurance
Camarillo, CA, US
Pay Rate Low: 36 | Pay Rate High: 38
+ Added - 05/09/2025
Apply for Job
_Our client, a global CDMO, offering products and services across the drug development spectrum is looking for a skilled Sr. QC Analyst to join their team in Camarillo, CA!_
**Job Title:** Senior QC Analyst
**Location:** Camarillo, CA
**Pay rate:** $37 - $39/ hr.
**Job Summary:**
We are seeking a highly skilled and detail-oriented Senior QC Analyst to perform complex analytical testing in support of pharmaceutical product development and manufacturing. The ideal candidate will have advanced experience in chromatography techniques (e.g., HPLC, UPLC, GC), method validation, data analysis, and regulatory compliance. This position plays a critical role in ensuring product quality, supporting investigations, and driving continuous improvement across the QC function.
**Key Responsibilities:**
+ Perform complex analytical testing including Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), and other instrumental and wet chemistry techniques.
+ Troubleshoot analytical instruments and resolve method or equipment-related issues.
+ Participate in and assist with test method validations, verifications, and transfers.
+ Evaluate and analyze test data to identify trends, outliers, or potential issues.
+ Support OOS (Out of Specification) and OOT (Out of Trend) investigations, including CAPA (Corrective and Preventive Action) documentation.
+ Coordinate testing activities with external laboratories, including raw material and specialized testing.
+ Execute, author, and review SOPs, test methods, protocols, reports, investigations, change controls, and data summaries.
+ Utilize risk assessment and root cause analysis tools (e.g., 5 Whys, Fishbone) to support investigations and process improvements.
+ Manage aspects of the stability program, including scheduling, testing, and reporting, and investigate aberrant stability results.
**Qualifications:**
+ Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
+ 3-6+ years of relevant experience in a regulated laboratory environment (pharmaceutical, biotech, or similar).
+ Strong technical expertise in HPLC, UPLC, GC, and other analytical techniques.
+ Working knowledge of cGMP regulations, ICH guidelines, and regulatory expectations.
+ Experience with method validation and stability programs preferred.
+ Ability to manage multiple tasks and work independently in a fast-paced environment.
+ Experience with electronic data systems (e.g., Empower, LIMS, TrackWise, MasterControl).
_Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_
#INDBH
#LI-DNP
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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