Material Sciences Specialist Location: Novato, CA Hybrid/Onsite Tuesdays & Wednesdays
Pay Rate: $55 $60/hour
Contract: W-2 Contract through March 2027
Position Summary
We are seeking a Material Sciences Specialist to support a global material specification remediation program within a leading pharmaceutical organization. This position will support regulatory commitments and CAPA activities by reviewing, updating, and implementing raw material specifications in accordance with current compendial, quality, and internal requirements.
The ideal candidate will have a strong background in GMP environments, raw material specifications, pharmacopeial standards, technical documentation, change controls, and CAPAs.
Key Responsibilities- Review existing raw material specifications against current compendial requirements.
- Compare USP, Ph. Eur./EP, JP, Client, and supplier specifications as applicable.
- Revise specifications for excipients, chemicals, and process materials.
- Compile technical documentation and supporting rationale for specification updates.
- Support initiation and execution of change controls and CAPA-related activities.
- Coordinate impact assessments and follow up with cross-functional SMEs on outstanding actions.
- Maintain specification inventories, implementation trackers, and status reports.
- Verify technical data consistency across specifications and supporting documentation.
- Ensure documentation meets approved GMP and specification templates.
- Support inspection readiness and preparation of documentation for regulatory inspections and CAPA effectiveness reviews.
- Collaborate with Material Sciences, Quality, QC, Regulatory Affairs, Manufacturing, Supply Chain, and Procurement teams.
Required Qualifications- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
- 3 4+ years of experience within pharmaceutical/biotech manufacturing, Quality, QC, Material Sciences, Technical Services, or Regulatory Compliance.
- Experience working with GMP/cGMP documentation.
- Strong technical writing and controlled-document revision skills.
- Experience with CAPAs, change controls, and/or deviation systems.
- Working knowledge of pharmacopeial standards, including USP, EP/Ph. Eur., and JP.
- Ability to independently manage multiple priorities and work cross-functionally.
Preferred Qualifications- Experience developing or maintaining raw material, excipient, or chemical specifications.
- Knowledge of supplier quality systems and raw material control strategies.
- Experience supporting regulatory remediation programs or inspection readiness.
- Experience with Veeva, electronic quality systems (eQMS), or document management systems.
- Previous experience within a regulated pharmaceutical or biotechnology environment.
Please submit your resume in Word or PDF format to be considered.