Quality Control Specialist
• Independently perform a technical review of data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots.
• Create and revise QC Standard Operating Procedures, Test Records, Stability and Assay Qualification Protocols and Reports to ensure compliance with the requirements of the QC Analytical laboratory and various regulatory agencies.
• Ensure Completion of Periodic/Biennial Review of documents.
• Support investigations (OOS/OOT, deviations, etc), CAPAs, Change Controls, and Planned Variances that occur within the QC laboratory
• As needed, review results and deviations/ investigations from Contract Testing Laboratories (CTLs) as well as our in-house microbiology group.
• Other duties as assigned by supervisor.
• A Bachelor’s degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.
• One to three years of appropriate experience. College coursework may substitute at an equivalent rate for the required experience.
• Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position. QA or QC experience in analytical testing and development is strongly recommended.
Knowledge, Skills, Abilities
• Proficiency with Microsoft office programs such as Word, Excel, and PowerPoint.
• Excellent technical writing and oral communication skills are required.
• Previous experience with Laboratory Information Management Systems and other Electronic Document Systems (eg. Trackwise, Documentum, etc) is recommended.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
• Ability to communicate/work in a high pressure/high paced environment.
• Ability to multi-task and function effectively as a member of a team.