Food Safety & GMP Quality Assurance Consultant Part time (Remote)
Frederick or North Carolina or Maryland
$63-$77/hrRemotePart Time
Pace Analytical: Provides analytical testing and scientific laboratory services.
15+ YOEBachelor's in a relevant science,15+ years QA/food safety experience,knowledge of FDA/FSMA/21 CFR/HACCP/GMP,GFSI auditing experience,PCQI/HACCP or Lead Auditor preferred,travel availability.
PrecigenNASDAQ: PGEN: Develops precision gene and cell therapies for intractable diseases.
1+ YOE1-3 years GMP or sterile cleaning experience in pharma/biotech; able to don cleanroom gowning and PPE, lift up to 40 lbs, stand/walk/squat for long periods, follow SOPs and document work.
CAMRIS International: Provides professional scientific research and program management services.
10+ YOEBS/BA in business or engineering with 10 years biologics development or manufacturing experience; MS Project; MS Office; knowledge of GMP; eligible to work in the US without visa sponsorship.
MS Project, MS Excel, MS Word, MS SharePoint, MS Teams, Smartsheet
QIAGENNYSE: QGEN: Provider of sample and assay technologies for molecular diagnostics.
4+ YOEBachelor’s in science/engineering with 6 years GMP manufacturing experience, or Master’s with 2–4 years; GMP/ISO biotech experience; NGS library prep; proficiency with lab equipment; Lean and SAP knowledge beneficial.
GMP, ISO, QSR, Laboratory equipment, Microsoft Office, SAP, Lean
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
5+ YOE5+ years relevant GMP experience (5+ with MS or 7+ with BS/BA). Proficient with GMP/GLP, QA principles, Microsoft Office; experience managing deviations, CAPAs, change controls, batch review, and audits.
GMPs, GLPs, Microsoft Office, Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC), Hazard Analysis and Critical Control Points (HACCP), Failure Mode Effects Analysis (FMEA)
Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)
Research Triangle Park or Silver Spring
$88k-$135k/yrOnsiteFull Time
United TherapeuticsNasdaq: UTHR: Develops rare disease therapies and manufactured transplantable organs.
5+ YOEBachelor's in science/engineering,5+ years auditing/supplier management in FDA-regulated pharma/device industry,strong cGMP knowledge,valid passport,attention to detail and communication skills.
Microsoft Word, Microsoft Excel, Microsoft Power Point, SAP, Trackwise Digital, MasterControl
LifeSprout: Developing regenerative biomaterials for aesthetic and reconstructive medicine.
3+ YOEBachelor’s in chemistry/chemical engineering/materials science/biomedical engineering or 3+ years in medical device/pharma manufacturing; hands-on materials processing and GMP experience.
Samsung BiologicsKorea Exchange: 207940: Global contract development and manufacturing organization for biopharmaceuticals.
1+ YOEAt least one year of directly related pharmaceutical or biotechnology manufacturing experience; ability to follow GMP documentation, safety procedures, SOPs, and operate process equipment.
Merck KGaAFrankfurt Stock Exchange: MRK: Science and technology in healthcare, life science, and electronics.
3+ YOEPhD in science, or master's with 3+ years, or bachelor's with 4+ years of scientific laboratory experience; requires virology, cell culture, aseptic technique, and GMP/GLP knowledge.
Microsoft Word, Microsoft Excel, Oracle, LIMS, BRIQS, SOPs, cGMP, GLP
AmcorNYSE: AMCR: Develops and produces flexible and rigid packaging solutions globally.
Forklift certification and successful written and performance evaluations required. Must understand warehouse systems, inventory procedures, GMP, SQF, food safety, security, and quality compliance.
BioNTechNASDAQ: BNTX: Developing individualized cancer immunotherapies and infectious disease vaccines.
10+ YOEAdvanced degree in a relevant life-science field, 10+ years in regulated pharmaceutical environments, biological analytical methods expertise, GMP and ICH knowledge, and regulatory filing experience.
Principal Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations
Gaithersburg, Maryland, United States
$122k-$183k/yrOnsiteFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
4+ YOERequires a relevant bachelor's, master's, or doctoral degree and 4–10+ years of cell therapy, biologics, or vaccine industry experience, plus GMP, technology transfer, validation, CPV, and CMC expertise.
Continued Process Verification (CPV), GMP, ICH, INDa, BLA, MAA
BioNTechNasdaq: BNTX: Develops mRNA-based immunotherapies for cancer and infectious diseases.
6+ YOEMS or PhD in biochemical engineering, chemical engineering, pharmaceutical sciences, or related field; 6+ years industry experience; expertise in CMC, raw materials, GMP, risk assessment, and lifecycle management.
Northeast Foods: A food manufacturer focused on producing bakery products while maintaining high standards of food safety and quality.
Experience in food or beverage manufacturing with strong knowledge of HACCP, GMP/CGMP, ISO 9001, FDA regulations, quality audits, CAPA, Six Sigma and Lean; training and project management experience.
HACCP, GMP, CGMP, ISO 9001, FDA, Six Sigma, Lean, GD&T, GxP
Keany Produce & Gourmet: Distributes fresh produce and gourmet foods to foodservice providers.
Experience in food production or meat processing preferred; work in cold environments; follow GMPs and USDA rules; stand for long periods; read production paperwork; reliable with weekend/holiday availability.
Knife handling, PPE, Sanitation equipment, GMPs, Production equipment
The Chefs' WarehouseNASDAQ: CHEF: Distributes specialty food products to restaurants and culinary professionals.
0.25+ YOEHigh school diploma or equivalent, 3–6 months of experience, ability to safely lift, carry, and move objects weighing up to 50 pounds, and follow HACCP, OSHA, and GMP guidelines.
1+ YOEBS or MS in molecular biology/biochemistry/microbiology,1–3 years lab experience,PCR/qPCR and assay development experience,QC/GMP exposure preferred,strong analytical and communication skills.
PCR, qPCR, ELISA, Western blot, flow cytometry, GMP