Job Specifications
Contract – Potential to last up to 6 Months, to start
Norwood, MA
PR: $45-56/hour
Shift: Monday through Friday, 9am-5pm
Job Summary
The role requires a strong blend of on-the-floor GMP oversight and advanced quality documentation leadership, focusing on drug product manufacturing. You will be responsible for authoring and approving critical quality documentation (including SOPs, specifications, change controls, and validation packages) and taking the lead on batch review and final product disposition. Furthermore, this specialist will lead cross-functional investigations (Deviations/CAPAs) and strategically support validation and tech transfer activities for late-stage development programs, ensuring processes are robust, compliant with FDA/EU/ICH regulations, and scalable. This position is ideal for someone with 3–5 years of QA experience in an aseptic environment who is ready to lead improvement initiatives and provide real-time guidance to manufacturing teams.
Job Responsibilities
GMP Documentation
Write, review, and approve SOPs, tech-transfer protocols, specifications, change controls, validation protocols/reports, and summary reports.
Batch Review & Disposition
Examine batch and testing records, verify compliance with all limits/specifications, and execute final product disposition/release.
Deviation & CAPA Management
Lead or support investigations (process, equipment, OOS) and implement effective corrective/preventive actions.
Validation & Tech Transfer
Assess and approve process/cleaning validation packages; ensure late-stage development activities meet validation standards.
Facility & Equipment Support
Review/approve work-order and return-to-service packages; support start-up readiness for new aseptic fill-finish suites.
Cross-Functional Leadership
Facilitate initiatives that enhance operational efficiency and quality culture across Manufacturing, QC, Engineering, and Supply Chain.
On-the-Floor QA Guidance
Provide real-time GMP oversight and coaching during drug product manufacturing activities.
Additional duties as may be assigned from time to time
Education & Qualifications
Required
BS/MS in Life Sciences, Engineering, or related field.
3–5 years' experience in biotech/pharma QA within aseptic fill-finish operations
Preferred
Auditing experience
Strong grasp of FDA, EU, and ICH cGMP regulations
Familiarity with late-stage development and validation principles
Experience with electronic quality systems.
Prior experience with any type of start-up work
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
About the Company
Randstad North America, Inc. is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider. Driven to become the world's most valued 'working life partner', supporting as many people as possible in realizing their true potential throughout their working life, we provide companies with the high quality, diverse, and agile workforces they need while helping people get rewarding jobs and stay relevant in the ever-changing world of work. In 2021, Randstad had on average 39,530 corporate employees and ge...
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