Quality Assurance Specialist

Discover International; Boston (MA); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Discover International in Boston, MA, is seeking a QA professional to support biotech manufacturing See full job description for responsibilities and qualifications. The role features a hybrid schedule with three onsite days per week and remote work with monthly office visits for team interactions.

The candidate will review CDMO records, assess quality events, and ensure cGMP disposition of materials used in clinical programs.

Qualifications

• Bachelor's degree in life sciences or related field.
• 3+ years GMP quality experience in biotech/pharma.
• Experience with external manufacturing and supplier quality oversight with a CMDO.
• Strong knowledge of GMP regulations (FDA, EMA, ICH).
• Experience with batch review and disposition.
• Experience with biologics manufacturing processes.
• Excellent communication and interpersonal skills.
• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.

Responsibilities

• Review of Drug Substance and Drug Product CDMO manufacturing records.
• Review Quality Events (deviations, OOS) related to manufacturing of clinical material lots.
• Provide cGMP disposition of Drug substance / Drug product.

Skills

GMP knowledge

Quality oversight

Communication

Problem solving

Education

Bachelor's degree in life sciences

Job description

This role is based in Boston with a hybrid schedule (three days onsite per week) however may be remote with monthly office visits for team interactions.

Responsibilities

• Review of Drug Substance and Drug Product CDMO manufacturing records.
• Review Quality Events (i.e. deviations, OOS) relating to the manufacturing of clinical material lots.
• Provide cGMP disposition of Drug substance / Drug product.

Qualifications

• Bachelor's degree in life sciences or related industry experience.
• 3+ years of GMP Quality experience in biotech/pharma.
• Experience with external manufacturing and supplier Quality oversight with a CMDO
• Strong knowledge of GMP regulations (FDA, EMA, ICH).
• Experience with batch review and disposition.
• Experience with biologics manufacturing processes
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.