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Gmp Analyst Jobs

Senior Manager, Gmp Compliance
By Skills Alliance At Newark, CA, United States
Collaborates with management to identify, evaluate, and recommend solutions to issues identified during performance of GMP audits.
Develops and provides meaningful metrics and trends to Management.
Follows instructions and responds to management direction; Takes responsibility for own actions.
Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
Complete other responsibilities, as assigned.
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.
Gmp Training Manager Jobs
By Advanced Recruiting Partners At Atlanta, GA, United States
Monitor training certifications and re-certification requirements for specific processes, as applicable
Maintain up-to-date training records and ensure employees have completed all required training; report status and results to management as requested
ESSENTIAL DUTIES AND RESPONSIBILITIES:Lead and develop a team of trainers on the Operations team
Develop and conduct new hire and ongoing training and education in the areas of tissue processing, safety, quality, etc.
Conduct regular and annual audits of team to ensure compliance with manufacturing procedures (Good Manufacturing Process (GMP)) and quality requirements
Aligns the qualification training program needs with Manufacturing and Quality Control areas.
Sr. Manager, Gmp Compliance
By CymaBay Therapeutics At Newark, CA, United States
Collaborates with management to identify, evaluate, and recommend solutions to issues identified during performance of GMP audits.
Develops and provides meaningful metrics and trends to Management.
Follows instructions and responds to management direction; Takes responsibility for own actions.
Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
Complete other responsibilities, as assigned.
Qa Gmp Contractor Jobs
By Astex Pharmaceuticals At , Pleasanton, Ca $85 - $105 an hour
Manage the stability programs using both paper based and electronic stability management system (IStability)
Provide support for vendor management activities
Proficiency using MS Office, TrackWise, Learning Management System (LMS), Stability Management Systems (IMS), Electronic Document Management System (EDMS) and SharePoint
Manage and support analytical and technical functions within the Quality Assurance department.
Manage CMO Quality documents within SharePoint
Initiate follow-up on investigations, deviations and corrective action(s) generated during annual audit, for-cause audit, and qualification audits
Gmp Manufacturing Supervisor Jobs
By Takeda Pharmaceutical At , Social Circle, 30025, Ga
Escalation and management of program execution gaps
Respond to detailed inquiries, and present information to groups and senior management.
Align program requirements (Global, GMP, continuous improvement)
Demonstrate interpersonal and leadership skills with the ability to work with well with other departments, and lead in a team environment.
Manage various processes in a manufacturing plant setting.
Experience with GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
Senior C&Q/Validation Engineers-Gmp/Pharma
By Process Engineering Specialists At Indiana, United States
Participate in the CQV of process/FUE and cleaning validation.
Using the process automation system for the commissioning and validation of process equipment.
Protocol Development (IQ,OQ, PQ) / protocol review for process equipment/FUE and/or cleaning validation.
Interface with client personnel and with outside vendors when necessary while performing the above.
If you'd like to find out about this opportunity, please forward your CV to Nelson Anthony ([email protected]).
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 ...

Gmp Document Reviewer Jobs
By Quotient Sciences At Boothwyn, PA, United States
Quality Tracking & Presentation skill.
Clear Communication skill (Verbal and written).
Knowledge of pharmaceutical unit process for solid dosage form and GMP documentation process.
Working knowledge of Quality Systems such as line clearance, logbook entries and other QA related activity preferred.
Main Tasks And Responsibilities Will Include
Address client comments and support comment resolution when needed.
Scientist I/Ii - Exploratory R&D Gmp
By BioLegend At San Diego, CA, United States
Minimum Qualifications – Education And Experience
Preferred Qualifications – Education And Experience
Other projects or responsibilities as may be required.
M.S. with generally more than 8 yrs of relevant working experiences.
Ph.D. with generally 2-4 years of post-doctoral training or relevant working experiences
Experience in process development and optimization for stem cells and/or hybridoma cell culture
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.
Director, Qa Gmp Manufacturing
By Advanced Clinical At Miami-Fort Lauderdale Area, United States
Required Education, Experience and Certifications:
· Ability to influence senior management, peers and other colleagues without direct reporting lines
** Note: Prior Pharmaceutical / Biotechnology Experience Required
· Previous virtual manufacturing / CMO Oversight experience preferred
Domestic and International travel up to 25% of time may be required
· Ensure all API, drug product and investigational product batches are released on time
Associate Scientist I, Gmp Manufacturing - Downstream
By BioSpace At Columbus, OH, United States
Additional responsibilities not listed may be assigned as needed by management.
Plans work to meet production and schedule requirements from clients (internal and external).
Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience)
Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
Working knowledge of cGMP and ISO guidelines
Wellness benefits (financial planning services, mental health counseling, employer paid disability)
Gmp Business Operations Manager
By Duke University At , Durham, 27710, Nc
Develop a process to ensure adequate effort management post award.
Maintain communication with DHVI, GMP, and Program Management leadership to report and address business and financial issues in a timely manner.
Assess the maintenance plan and coverage for all GMP and evaluate the strategic plan to allocate these costs.
Work with teams across the GMP program to accelerate the timelines for producing mRNA/LNP and protein vaccine candidates.
Support GMP senior leadership business decision-making by managing, prioritizing, and synthesizing operational, space, and financial needs.
Perform other duties as assigned by GMP and DHVI leadership.
Documentation Management Specialist With Gmp Experience
By Synectics Inc. At Summit, NJ, United States
Ensure compliance within the organization as it pertains to documentation and records management.
Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. DocMan) and Records Management Systems.
Serves as Records Management System (RMS/Celdox) Subject-Matter-Expert (SME) to enable successful execution of workflows within the system.
Utilize the Electronic Document Management System (EDMS) to manage hardcopy GMP documents submitted for retention and archival.
Provide support for procedural documentation requests, records management, issuance of logbooks/notebooks issuance, tracking and reconciliation for the site.
Generate metrics and support communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction).
Gmp Analyst Jobs
By Eurofins At Indianapolis, IN, United States

Excellent full time benefits including comprehensive medical coverage, dental, and vision options

Document test results in notebooks and reports