How does it sound to be part of a groundbreaking Biotechnology company pioneering in harnessing the power of mRNA technology creating innovative medicines and vaccines? We’re looking for a detail-oriented and proactive Stability Documentation Specialist to oversee data readiness and document management across our global stability team. In this dynamic role, you’ll play a key part in coordinating critical stability documentation, collaborating with QC stability and cross-functional teams, and ensuring adherence to GMP guidelines and regulatory commitments. APPLY TODAY.
Location: Norwood, MA.
Shift: M – F, 1st shift.
Pay Rate: $45 - $50/hour (based on qualifications and experience).
What you will be doing:
In this role, you will oversee data readiness and document management for the global stability team, focusing on timely submission and coordination of stability documentation. You'll collaborate with stakeholders to ensure GMP compliance and support QC teams with data verification and approval processes. Key Responsibilities:
- Coordinate with stability teams to ensure data readiness and timely Health Authority (HA) updates.
- Prepare, author, and maintain regulatory sections related to stability.
- Oversee creation of core data documents for regulatory submissions.
- Assist QC stability teams with data transcription and verification during process transitions.
- Ensure timely approval of core documents to meet submission deadlines.
- Support APQR stability section preparation and refine key global stability documents (e.g., Post-Approval Stability Protocols, OOT Forms, SOPs).
- Deploy stability strategy.
shift: First
work hours: 7 AM - 4 PM
education: Bachelors
The right candidate will have:
- Completed Bachelor’s Degree in Biology, Chemistry, Biochemistry, Chemical engineering, Biomechanical Engineering, Bioengineering, Biomedical Engineering, or related STEM field discipline.
- 2-5 years’ experience in the biotechnology/biopharmaceutical industry, or other cGMP regulated industry.
- Project management skills: Ability to effectively manage data and document workflows using Advanced Microsoft Word and Excel.
- LIMS experience (i.e.: VEEVA).
- A general understanding of stability testing and protocols in a GMP environment.
TO APPLY: Email Resume to: claudia.mendoza@randstadusa.com
If this job is not for you, feel free to refer a friend.
Skills
- LIMS
- Veeva Vault
- Veeva
- stability studies
- stability testing
- biotechnology
- Biotech
- Pharmaceutical
- technical writing
- cGMP
- QC
- Quality Control
- Quality Assurance
- document management
- GMP
- data verification
- Microsoft Excel
- Microsoft Word
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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 health, an incentive and recognition program, and 401K contribution (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.
