Quality Control Manager

3 weeks ago

Somerville, United States Digital Prospectors Full time

Position: Quality Control Manager (Lab Operations)

Location: Somerville, MA (Onsite)

Length: 6+ months

Covid Requirements: N/A

Job Description:

Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality Control Manager will join the Quality Control team and assist in establishing GMP procedures required for a GMP laboratory as well as managing and performing GMP method performance to ensure readiness of quality control in-process, release, and stability test methods used for drug substances and products.

Essential Duties and Responsibilities (but not limited to):

  • Coordinate the operational functions of the quality control laboratory, including scheduling GMP testing, managing stability studies and logistics, overseeing sample management, and administering the critical reagent program.
  • Review quality control data from equipment and method qualifications, stability studies, and GMP testing.
  • Assist the method lifecycle lead in documenting and designing experiments for method qualifications and verifications.
  • Conduct analytical assays as part of method qualifications, verifications, and GMP testing (30% of time).

Qualifications:

  • Bachelors degree with 6+ years of related experience, Masters degree with 6 years of related experience, or PhD with 3 years of related experience.
  • Prior experience in Quality Control roles supporting GMP testing and manufacturing of gene therapy or gene editing products, ATMPs, or similar.
  • Proficiency in HPLC and UPLC-based assays and compendia assays (i.e., visual appearance, TOC, and conductivity).
  • Experience in supporting or leading laboratory operations such as logistics for GMP manufacturing, stability testing, sample inventory management, and critical reagent program management is advantageous.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Make this your next career move as one of our many long-term contractors or employees

  • Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

Come see why DPC has achieved:

  • 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 Employees Choice - Best Places to Work by Glassdoor.
  • Voted Best Staffing Firm to Temp/Contract For six times by Staffing Industry Analysts as well as a Best Company to Work For by Forbes, Fortune and Inc. magazine.

www.LoveYourJob.com

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