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Quality Assurance Gmp Trainer Jobs in Massachusetts

Senior Quality Specialist, Gmp Qa Operations
By Agenus At Lexington, MA, United States
Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.
Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.
EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.
Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production
Manager, Quality Assurance, Gmp
By Deciphera Pharmaceuticals At Waltham, MA, United States
Excellent interpersonal skill with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments.
Ability to manage multiple projects in a dynamic environment.
Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
Assure compliance (internally and externally) with 21 CFR 210/211, 312, EudraLex Vol. 4 (including relevant parts and annexes) and ICH.
Provide GMP oversight of daily quality related tasks and priorities of the clinical and commercial partners.
Review and Approve Master Batch Production Records and Executed Batch Production Records.
Gmp Quality Specialist Jobs
By Amylyx Pharmaceuticals At Cambridge, MA, United States
General knowledge of CMC and Regulatory Filing requirements.
Minimum 1 year of experience within the Pharmaceutical or Biotechnology industry in a Quality role. QC experience is a plus.
Experience with small molecules and oral dosage forms is highly preferred.
Knowledgeable in FDA cGMP regulations, EudraLex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
Clinical knowledge in neurodegenerative diseases (i.e., ALS, Alzheimer's disease).
Experience in supporting functions during FDA, EMA, or other regulatory agency inspections.
R&D Quality Assurance Pharma Biotech - Gmp Qa Manager
By BioSpace At Boston, MA, United States
Supports GMP SupplierQuality Management activities, including qualification and Quality technical Agreements, for programs/products that are assigned.
Knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry and subsequent applications to pharma drug development.
Demonstrated teamwork, initiative, and problem solving skills required.Ability to anticipate issues and manage a team to proactively implement solutions.
Independently manage projects/programs and make sound decisions with guidance in some difficult occasion.
Minimum of 5 years of increasingly responsibility and experience in pharmaceutical manufacturing, packaging, laboratory or QA/QC/Compliance environment.
Interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Takeda
Sr. Director, Gmp Quality Assurance Operations
By Moderna At Norwood, MA, United States
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Ensure the quality policy and objectives are understood, implemented, and maintained at all levels of the organization.
Develop short and long-term plans to achieve both quality and business objectives.
Provide guidance, support and oversees all activities related to batch record review and product disposition for internal Manufacturing at Moderna Inc.