Senior Specialist, Quality Assurance – Drug Product
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Job Description
Senior Specialist in Quality Assurance focused on drug product compliance and manufacturing support. Role includes batch review, vendor oversight, and collaboration on GMP processes.
Responsibilities:
- The Senior Specialist, Quality Assurance – Drug Product is responsible for executing quality assurance activities that support clinical and commercial manufacturing operations in compliance with cGMP standards.
- This role focuses on batch record review, vendor oversight, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations.
- The individual will work closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations.
- Success in this role requires strong attention to detail, the ability to manage multiple priorities, and effective cross functional collaboration to ensure timely batch disposition and compliance.
- The position serves as a key contributor within the QA team, supporting inspection readiness and the ongoing operation and continuous improvement of the GMP Quality System, while also providing occasional support for clinical labeling, drug substance contract manufacturing, and other QA activities as needed.
Requirements:
- Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).
- Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry.
- Direct experience supporting GMP-regulated drug product manufacturing, including batch record review and documentation compliance.
- Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity.
- Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations.
- Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug product manufacturing.
- Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data).
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Proficiency with electronic quality systems and document management platforms.
- Ability to travel domestically and internationally (~20%) as needed.
Benefits:
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2026 we will observe 14 holidays
- RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
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