QC Analyst II, Quality Control Microbiology

Innova Solutions Inc; Woburn (MA); Sur place; USD 62 000 - 69 000; Plein temps

Avantages offerts par ce poste

Medical & pharmacy coverage

Dental/vision insurance

401(k)

HSA/FSA

Résumé du poste

Innova Solutions is seeking a QC Analyst II to support gene therapy programs by executing GMP microbiological assays including endotoxin, bioburden, TOC, and growth promotion. You will perform routine testing, review GMP data, and support laboratory operations while ensuring readiness and participating in continuous improvement.

The role involves SOP updates, data management, and peer reviews, with a 9:30 AM–6:00 PM, Monday–Friday schedule at our MA location.

Qualifications

• BS or MS in Microbiology or related discipline with 2+ years industry experience.
• GMP QC microbiology experience required.
• Hands-on microbiological testing (bioburden, endotoxin, TOC, etc.).

Responsabilités

• Perform routine QC microbiology testing of product and water samples.
• Review GMP analytical data and support lab operations.
• Ensure lab readiness and assist with troubleshooting/continuous improvement.
• Revise SOPs, forms, protocols and data reports.

Connaissances

Hands-on microbiology testing

GMP compliance

Data management

Formation

B.S. or M.S. in Microbiology or related field

Outils

Excel

Microsoft Word

Computerized systems

Description du poste

Role Responsibilities

the QC Analyst II role will support the gene therapy program pipeline through the execution of GMP microbiological assays including, but not limited to, endotoxin, bioburden, total organic carbon (TOC) and growth promotion.

• Performs routine Quality Control microbiology testing of product and water samples. Testing includes bioburden, plate reading, endotoxin, total organic carbon, conductivity and media growth promotion.
• Conducts review of GMP analytical data.
• Supports routine laboratory operations (data management, equipment cleaning, laboratory cleaning, inventory control and logbook management)
• Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
• Revise SOPs, forms, protocols, data reports, and other controlled documents relating to QC microbiology testing and instrumentation.
• Performs peer review of both internal and externally generated data, as needed.
• Supports QC deviations, investigations, root cause analysis, change control, and CAPA as needed.

Shift: 9:30 AM - 6:00 PM, Monday - Friday.

Requirements

• BS or MS in Microbiology or a related discipline with 2+ years industry experience. QC GMP experience is required.
• Hands-on experience with performing microbiological analytical testing (bioburden, endotoxin, TOC, etc..) required.
• Proficient in the use of computerized systems.
• Experience with Excel and Microsoft Word.

Pay Range

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Pay Range*: $45- - $50 per hour

Benefits

• Medical & pharmacy coverage
• Dental/vision insurance
• 401(k)
• Health saving account (HSA) and Flexible spending account (FSA)
• Life Insurance
• Pet Insurance
• Short term and Long term Disability
• Accident & Critical illness coverage
• Pre-paid legal & ID theft protection
• Sick time
• other types of paid leaves (as required by law)
• Employee Assistance Program (EAP)

About Innova Solutions

Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recognition and Partnerships

Named One of America's Best Employers for New Grads by Forbes (2024)

Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)

One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)

One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)

Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)

One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)

AWS Advanced Tier Services Partner with 100+ certifications

Website: https://www.innovasolutions.com/

Referral Bonus

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.

Equal Employment Opportunity

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.

Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [emailprotected] or [phone]. Please indicate the specifics of the assistance needed.

Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.

Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.