SOKOL GxP Services provides comprehensive and cost-effective Commissioning, Qualification, and Validation (CQV) services to the pharmaceutical, biotechnology, and cell therapy industries. They specialize in ensuring facilities and equipment meet GxP regulatory requirements, offering services such as equipment qualification, facility & utility qualification, temperature mapping, and validation of critical systems like autoclaves and biological safety cabinets. SOKOL GxP distinguishes itself through a lean operational structure and a team of experienced, field-based experts, enabling them to consistently deliver projects on time and within budget while preparing clients for successful inspections. This makes them a valuable partner for companies seeking to navigate the complexities of regulatory compliance.
Open Positions
QC Microbiology Data Reviewer & GMP Documentation Specialist
4+ years GMP microbiology experience, intermediate SharePoint experience, LIMS experience, and Bachelor's degree in microbiology or related field
Assistant Process Engineer - Cell Therapy Raw Materials
Associate Engineer with B.S. or M.S. in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent required
Supply Chain Business Analyst (SAP ERP) - Cell Therapy Manufacturing
Bachelor's degree in Science, Engineering, or Supply Chain Management. 3+ years of experience with SAP ERP
QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift
Bachelor's degree in a scientific discipline; 1+ years of labeling experience in a cGMP/FDA-regulated biopharma environment; 3+ years of experience using MS Office 365
Assistant Scientist - Cell Therapy / Cell Manufacturing
A.A. in Lab Technology or B.S. in Biology, Chemical Engineering, Bioengineering, or related field. 0–2 years of industry bioprocess or relevant laboratory experience
Statistician - CMC & Biopharmaceutical Manufacturing
Requires an M.S./PhD in Statistics/Biostatistics. 3+ years of statistical experience & software proficiency. Data analysis experience (Biopharma preferred)
Technical Writer - CMC Regulatory Submissions (Hybrid, New Brunswick)
Bachelor's degree in biology or related. 2+ years biotech experience with a focus on CMC documentation. Expertise in regulatory requirements and eCTD structure
Scientist - GMP Quality & Technical Writing (Hybrid, Devens MA)
Bachelor's/Master's degree in related field. 2+ yrs exp. or PhD. Strong technical writing skills, GMP documentation experience, & ability to work cross-team
Junior Calibration & Equipment Support Engineer
Bachelor's degree in a related field. 1-3 years of exp in equipment calibration/support in cGMP. CMMS experience preferred
QA Document Control Specialist II (GMP)
Bachelor’s degree required; 3+ years of document control experience; strong understanding of cGMPs
+15 More Jobs Available!
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