Quality Assurance Specialist

2 weeks ago

Woburn, Massachusetts, United States Digital Prospectors Full time
Job Description

Job Title: Quality Control Consultant

Job Type: Full-time or Contract

Location: Remote or Onsite

Job Description:

We are seeking a highly skilled Quality Control Consultant to join our team at Digital Prospectors. As a pivotal member of our team, you will support various routine activities, including release and stability testing, reagent preparation, and data integrity reviews.

Key Responsibilities:

  • Quality Control: Evaluate and approve cGMP analytical data for release and stability testing using bioassay test methods such as mRNA expression, functional potency, and ELISA testing platforms.
  • Data Integrity: Perform data integrity reviews (data verification) to support validation, qualification, and analytical method trending reports as needed.
  • Laboratory Operations: Support routine Laboratory Operations including, but not limited to:
  1. Logbook Review: Review logbooks for reagent preparation, equipment, and critical reagent tracking.
  2. Walkthroughs: Conduct weekly laboratory housekeeping walkthroughs.
  3. Reagent Preparation: Prepare reagents and perform cell passaging.
  • Quality Events: Author and support quality events including change controls, deviations, CAPAs, and OOS Investigations as required.
  • Technical Documents: Author analytical method performance trend reports and other technical documents as needed.

Requirements:

  • Education: Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, or a related discipline.
  • Experience: Minimum of 5 years of industry experience in a similar role.
  • Skills: Proven experience in mammalian cell culture and biological methods, including immunoassays, cell-based assays, and quantitative PCR. Familiarity with GMP and GLP environments is essential.
  • Software: Experience with statistical analysis software (i.e., SoftMax or JMP) is preferred.
  • Personal Qualities: Ability and enthusiasm to work in a fast-paced environment. Strong collaboration, teamwork, and communication skills. Independently motivated, detail-oriented, and adept at problem-solving.

What We Offer:

  • Benefits: 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.
  • Company Culture: 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 'Employee's Choice - Best Places to Work' by Glassdoor.

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