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Material Sciences Specialist

System One • Novato, CA • 4d ago

Job Title: Material Sciences Specialist

Location: Novato CA 94949

Type: Contract

Compensation: $57-$62.07

Work Model: Hybrid - onsite and remote

Hours: 8-5 MF (Tuesday and Wednesday onsite)

Overview

Leading biotechnology company looking for an experienced Material Sciences Specialist. Ideal candidates should have a bachelors degree 3-4 years of experience in pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance.

Responsibilities

Support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities.

Work with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements.

Review existing raw material specifications against current compendial requirements, including USP, Ph. Eur., JP, ACS, and supplier specifications where applicable.

Support revision of excipient, chemical, and process material specifications.

Compile technical justification packages and supporting rationale for specification updates.

Support initiation and execution of change controls related to specification updates.

Coordinate impact assessments from affected functional groups and track implementation progress and CAPA milestones.

Maintain specification inventories, generate summary reports, and verify data consistency across documents.

Collaborate with cross-functional teams including Material Sciences, Quality Systems, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement.

Assist with meeting preparation, impact assessment follow-ups, and action tracking.

Prepare documentation for regulatory inspections and CAPA reviews.

Ensure specifications align with regulatory expectations and are inspection-ready.

Requirements

BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.

3-4 years of experience in pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance.

Experience working with GMP documentation.

Strong technical writing and document revision skills.

Familiarity with change controls, CAPAs, and deviation systems.

Knowledge of pharmacopeial standards (USP, EP, JP).

Experience with raw material specifications and supplier quality systems (preferred).

Understanding of excipient and chemical control strategies (preferred).

Support experience with regulatory inspections or remediation programs (preferred).

Familiarity with Veeva, document management systems, and electronic quality systems (preferred).

Ability to independently manage multiple workstreams and priorities.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

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