Scientist – GMP Quality, Technical Writing
SOKOL GxP Services
contract
Posted on:
Location Type: Hybrid
Location: Devens • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $67 - $75 per hour
Job Level
JuniorMid-Level
About the role
- Qualify alternative raw material suppliers and partner with Procurement to identify new options.
- Recommend and lead necessary testing to qualify materials for GMP manufacturing.
- Author technical equivalency assessments, specification comparisons, material characterization reports, and change controls.
- Support material and consumable manufacturing investigations.
- Manage supplier change notifications and evaluate risks to maintain GMP compliance.
- Contribute to risk assessments and material specification development.
- Partner with cross-functional teams to deliver results in a fast-paced, matrixed environment.
Requirements
- Bachelor’s or Master’s degree in Material Science Engineering, Chemistry, or related field with 2+ years of industry experience, or a PhD.
- Strong technical writing skills and ability to author GMP documentation.
- Experience in cross-matrix team environments and stakeholder collaboration.
- Proven ability to manage multiple projects in a fast-paced setting.
- Independent contributor with strong communication and interpersonal skills.
- Experience with GMP change controls and investigations preferred.
- Familiarity with analytical techniques (FTIR, SEM-EDS, etc.) and data trending/analysis a plus.
- Awareness of cGMP regulations and compliance requirements.
Benefits
- Competitive hourly rate: $67.20 – $75.20/hr (W-2 only, no C2C)
- Hybrid schedule (50% onsite Tue–Thu; full onsite during the first month)
- 12-month contract with possible extension
- Health benefits, holiday pay, and 401(k) program
- Paid time off (UTO) and professional development support
- Employee referral bonus program
- Opportunity to contribute to high-impact projects with a leading biopharma company
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP documentationtechnical writinganalytical techniquesFTIRSEM-EDSdata trendingdata analysismaterial characterizationrisk assessmentsmaterial specification development
Soft skills
communicationinterpersonal skillsproject managementstakeholder collaborationindependent contributorfast-paced environmentcross-functional teamwork
Certifications
Bachelor’s degreeMaster’s degreePhD