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Quality Assurance Gmp Trainer 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
Associate Director / Director, Quality Assurance (Gmp And Gcp)
By Ocugen Inc At , Malvern, 19355
Proven background in GCP and GMP audit management, risk management, mitigation, and controls.
Job title is commensurate with experience and skills.
Develop and manage department budgets and long-range plans for the team
10+ years of relevant and current work experience in pharmaceutical QA/QC required.
Strong knowledge of biologics, gene and/or cell therapy manufacturing processes.
Hire, develop, and retain QA personnel to create a high-performing credible team.
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.
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.
Patient Access Trainer / Quality Assurance Auditor-Full Time
By Jennie Stuart Health At Hopkinsville, KY, United States
Analyze and identify quality performance trends at the employee and department levels. Prepare and analyze quality reports for management review.
Maintains hospital standards for a clean and quiet patient environment to maintain a positive patient care experience.
Maintains competency and knowledge of current standards of practice, trends, and developments in related scope of job role or practice.
Support and suggest improvements/recommendations to meet the highest level of patient experience.
3+ years Patient Access or Revenue Cycle Experience
Strong analytics and problem-solving skills
Associate Director, Gmp Quality Assurance
By BioSpace At South San Francisco, CA, United States
Knowledge of Quality Management Systems; experience in implementing and managing quality systems (paper based and Veeva EDMS) in the pharmaceutical industry.
Support the implementation of GMP and GLP activities as required by internal procedures and application of regulatory requirements.
Minimum 10 years of GMP Quality Assurance experience with GLP experience a plus.
Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.
Knowledge in clinical development to commercial is desired.
Hands-on experience in manufacturing and/or analytical testing and development.
Quality Assurance Trainer Jobs
By PSC Biotech At , Minnetonka, 55345, Mn
Oversee the training management system and ensure that all required training is efficiently assigned and deployed to team members.
Responsible for the training administration and assessment of all current training processes and requirements.
Drive process efficiency opportunities and continuous improvement.
Drive timely completion of training.
Ensure effective communication with team members and stakeholders.
Assess current training program and processes ensuring ISO regulations are met.
Gmp, Quality Assurance Associate I
By Duke University At , Durham, 27710, Nc
Have, organizational, and time management skills and the ability to handle a multitude of tasks.
Participate in Environmental Monitoring of facilities, as applicable. Work to recognize concerning trends associated with these data and alert management.
Work closely with Quality management to implement and enhance new and existing quality systems as directed.
In conjunction with other members of the QA Staff and/or Management:
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Experience in preparing for external audits or site visits.
Quality Assurance Specialist- Gmp/ Auditing
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Promote Quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System.
Assist with project management activities associated with quality projects, including maintenance of project information.
Provides oversight and development of Quality Management Systems (QMS)
5+ years drug manufacturing experience, and also looking for at least 5+ years of solid GxP auditing
Observe and adhere to applicable regulatory and legal requirements.
5 years of related experience or relevant pharmaceutical, health authority and/or CRO experience
Quality Assurance Associate Ii, Gmp Systems Compliance And Data Integrity
By Catalent At , San Diego, 92121, Ca $75,000 - $85,000 a year
Review and approval of equipment related documentation: Equipment onboarding, Calibration certificates/reports, Validation/qualification reports.
Assisting with plans, procedures, and requirements to address data integrity gaps for GMP systems.
Candidate must have 2+ years of work experience, preferable in a GMP manufacturing environment or similar.
Experience with equipment verification/calibration and supporting documentation highly desired.
Experience with Blue Mountain, TrackWise, and Microsoft Office preferred.
Medical, dental and vision benefits effective day one of employment
Quality Assurance Associate - Gmp Biomanufacturing Center
By CEDARS-SINAI At , Los Angeles, Ca $24.82 - $37.23 an hour
Assists with document control and records management.
No experience is required. Three (3) years of experience in Quality or Regulatory compliance is preferred.
Assist in the first-level enforcement of quality processes in compliance with quality procedures.
Assists review of manufacturing processes and cGMP documents following procedures and policies.
Assists in performing root cause analysis and establishing corrective and preventative actions.
Initiates corrective action in accordance with procedures.
Quality Control Associate I (Gmp Certificate Program)
By Stanford University At , Stanford, Ca
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Applicable or related experience in a laboratory, preferably a clinically related laboratory or demonstrated excellence in laboratory skills and methods.
Strong technical skills and some experience with testing QC methods and concepts.
Some knowledge of cGMP or International Organization for Standardization (ISO) requirements, quality systems.
Manage, maintain, monitor, and order QC raw materials and supplies
Strong team-oriented, interpersonal skills and collaborative work style.
Quality Assurance Associate (Gmp Certificate Program)
By Stanford University At , Stanford, Ca
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Bachelor’s degree and one year relevant experience or an equivalent combination of education and relevant experience.
Knowledge of GMP/ ISO compliance, and quality systems.
Applicable or related experience in a quality-related work in a cell therapy/biotech manufacturing setting
Experience with office software and database applications.
Excellent inter-personal skills and customer service focus.
Quality Assurance Specialist I, Gmp Manufacturing
By Seattle Childrens Hospital At , Seattle, 98105, Wa $67,454 - $101,192 a year
Min to Max Hourly Salary
Min to Max Annual Salary
The union pay ranges can be found on the Seattle Children's website here: WSNA - UFCW
Disclaimer for Out of State Applicants
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