In this role, you will drive and strengthen Moderna's aseptic fill-finish operations by providing on-the-floor GMP support, authoring and approving critical quality documentation, and leading cross-functional investigations and change controls to maintain robust, compliant, and scalable processes across CMC development programs. Focus on critical activities for start up of aseptic filling facility.
location: Norwood, Massachusetts
job type: Contract
salary: $40.00 - 52.26 per hour
work hours: 9 to 5
education: Bachelors
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
qualifications:
Required
- BS/MS in Life Sciences, Engineering, or related field.
- 3-5 years' experience in biotech/pharma QA, preferably with aseptic fill-finish operations
- auditing experience
- Strong grasp of FDA, EU, and ICH cGMP regulations
- familiarity with late-stage development and validation principles
- experience with electronic quality systems.
skills: SOP, GMP (Good Manufacturing Practice), Corrective and Preventive Actions (CAPA), Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
