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Gmp Specialist I Jobs

D&I Specialist Jobs
By The Phoenix Group At Washington DC-Baltimore Area, United States
Manage creation of pool and participant selection in non-Member/Partner leadership programs.
4+ years of diversity and inclusion experience in a professional services environment.
Possess excellent written and verbal communication skills.
Strong organizational and administrative skills.
Experience in statistical analysis preferred but not required.
Coordinate client requests, including data collection and analysis, and draft responses for client and industry survey inquiries and RFPs, as needed.
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 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.
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
Specialist I - Testing Specialist I (Part-Time, Hourly)
By Sam Houston State University At , Huntsville $15 an hour
This is a part-time, hourly, non-benefits eligible position working 19 hours or less per week.
Specialist I - Testing Specialist I (part-time, hourly) - 2 Positions to be Filled
Nature & Purpose of Position
Performs clerical and standardized test administration duties for the Testing Center.
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 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.
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
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

Gmp Manufacturing Scientist Jobs
By UC Irvine At Irvine, CA, United States

Please check our website for additional information

Gmp Production Cleaner Jobs
By BioSpace At Arcadia, CA, United States
Ability to check and respond to Equipment Monitoring System and Building Management Systems
Self-motivated, pays attention to details, and adapt to responsibilities outside of the initial job description
2-3 years of experience in GMP cleaning / cleanroom environment
Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
Must wear PPE due to safety requirements in designated lab areas
Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required
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.