QA Specialist - Full Time & Temporary
About The Position
The QA Specialist will provide Quality Assurance for Quality Control and Analytical Laboratories. Working in a fast-paced CDMO environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA expectations for QC activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to perform investigations, self-inspection audits, and analytical data review to maintain and expand Quality Control capabilities. In addition, the position requires someone with strong document management and change control experience in procedures used in GMP environment.
Requirements
- Bachelors’ or higher degree in sciences
- 2-4 years of combined manufacturing process development, manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
- 2-4 years experience in a GMP environment
- Knowledge of GMP regulations and guidance (such as US, EU, and ICH)
- Experience with Quality Assurance systems and processes
- Effective organization and planning skills
- Demonstrated ability to deal with frequent changes, delays, or unexpected events
- Strong technical writing skills
- Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Master Control (a plus)) and demonstrated troubleshooting and problem-solving techniques
- Ability to work under tight deadlines and pressure in a composed manner
- Effective interpersonal and communication skills
- Strong team player
- Comfortable communicating with all levels of staff, including executives
Nice To Haves
- Experience in manufacturing of drug substances or drug products is a plus
- Master Control (a plus)
Responsibilities
- Perform batch related records review
- Perform QA release of raw materials in QAD ERP System.
- Evaluate compliance of completed manufacturing records (sample plans, sample submission forms, etc.) and quality control records (test/analytical results)
- Evaluate document changes for compliance requirements (SOPs, Master Batch Records, specifications, test methods, etc.)
- Review all the supporting documents regarding Quality Control documentation including deviations (such as OOS), CAPAs, and change controls
- Collaborate with Manufacturing, Quality Control, and Analytical Development to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations
- Support cGMP compliance audits of GMP suppliers’ quality systems
- Support Document Control related processes
- Support and conduct training for employees, as necessary
- Perform other related duties as assigned from time to time based on company needs
Benefits
- growth opportunities throughout our companies
- a diverse environment to enhance your career
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
