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QA-QC Compliance Specialist (cGMP – Pharmaceutical – Analytical) JD819813

DPS Cambridge, MA Full-Time
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QA-QC Compliance Specialist (cGMP – Pharmaceutical – Analytical)        JD819813

Boston, MA area

DPS is seeking an established and knowledgeable QA-QC Specialist to work with a BioPharma client in the Boston, MA area. Successful candidates should have previous experience working with oral solid dose drugs and small molecule API.

Responsibilities:

  • Review stability and release analytical data, and related reports i.e. method transfers, validations, stability reports, and investigations).
  • Ideal candidates should have experience with: JMP statistical software,  performing stability trends, Veeva documentation system, and GMP laboratory experience with oral solid dose drugs and small molecule API.
  • Perform dissolution, HPLC, water content, release data review, and review trend reports.
  • Support method validation and method transfer as well as stability program.

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • 4+ years’ of experience in pharmaceutical, biotech or medical device industry
  • Previous direct lab experience required.
  • Previous experience supporting Oral Solid Dose (OSD) or API operations.
  • Excellent organizational skills and attention to detail.
  • Good verbal and written communication skills.
  • Strong interpersonal skills and ability to work efficiently on a team.

Recommended skills

Attention To Detail
Coordinating
Verbal Communication
Written Communication
Biotechnology
Interpersonal Skills
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Job ID: JD818692

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