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Gmp Quality Specialist Jobs

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
Gmp Quality Assurance Senior Manager
By Generate Biomedicines At , Boston
Timeline management and experience using internal and external resources to achieve objectives.
Experience in inspection readiness and management.
Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.
Analytical and problem-solving skills; experience in root cause analysis.
Develop and use Quality Agreements to manage vendor activities, outputs and records.
Solid experience working within US and EU GMPs.
Gmp Training Specialist Jobs
By Synectics Inc. At Summit, NJ, United States
Requires a high level of organizational and time management skills.
Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
Maintains the training status of new hires and communicates progress to Department Management.
Implements training programs that meet regulatory requirements and business needs
Works with the Manager on an on-going basis to implement training goals and meet KPI’s.
Collaborates with the Manager to ensure training is compliant and effective.
Quality Assurance Specialist - Gmp
By Revvity At , San Diego
Preferred Qualifications – Education and Experience
Investigate product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements
Participate in and support the facility in internal, customer, and third-party audits per ISO 13485 requirements
Create and modify SOPs with support from supervisor/manager
Other projects or responsibilities as may be required.
Knowledge of concepts, methods, terminologies, and tools of quality assurance
Assoc Gmp Quality Assurance Director - Clinical
By Exelixis, Inc. At , Alameda, 94502 $146,000 - $207,500 a year
Equivalent combination of education and experience.
Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,
MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,
PhD in related discipline and a minimum of 5 years of related QA experience; or
R&D Quality Assurance Pharma Biotech - Gmp Qa Manager (Hybrid)
By Takeda Pharmaceutical At , Boston, Ma
Supports GMP Supplier Quality 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
Quality Control Analyst- Pharma Gmp
By Integrated Resources, Inc ( IRI ) At United States

The Service QC Analyst position within the Global Service team provides a critical contribution to the overall quality and regulatory compliance of globally distributed field service teams. More ...

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.