Advance your life sciences career in Portsmouth, NH, with a top-tier global biopharmaceutical leader. We are seeking a detail-oriented QA Documentation Specialist 2 to oversee, review, and approve critical GMP and validation documentation supporting site-wide manufacturing, quality control, and automated systems.
location: Portsmouth, New Hampshire
job type: Contract
salary: $74.00 - 75.54 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and approve DMS documents, including initial and revised SOPs, Work Instructions, eBR, automation documentation, forms, and checklists.
- Review and approve electronic/paper validation and qualification documents, including protocols and summary reports for equipment, instrumentation, and computer systems.
- Review non-DMS site documentation, such as preventative maintenance records, CMMS forms, data sheets, and audit trail records.
- Serve as a Subject Matter Expert (SME) for QA document review across manufacturing, validation, MES, and quality control operations.
- Document review observations, suggest necessary revisions, and ensure all changes are appropriately justified and aligned with site procedures.
- Enforce strict Data Integrity principles across all quality systems and documentation practices.
qualifications:
Required:
- Bachelor's degree in a science-related field
- 5+ years of Quality Assurance experience in a regulated GMP environment
- Extensive experience reviewing quality assurance, equipment/cleaning validation, and Computer System Validation (CSV) protocols and reports
- Strong knowledge of GMP regulations (e.g., CFR 210, 211, 820, ICH guidelines)
- Hands-on experience with Document Management Systems (DMS) and Enterprise Quality Management Systems (e.g., TrackWise)
- Direct experience with LIMS, SAP, Syncade, or MES platforms
- Proven ability to manage medium-to-large QA projects and cross-departmental initiatives
skills: Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP), Quality Assurance (QA), International Council for Harmonization (ICH)
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.
