- 194046 - Quality Control Specialist
- $25 to $26.00 DOE
- 6 mos
- Chipton-Ross is seeking a Quality Control Specialist for an opening in Alachua, FL.
The QC Specialist will work with a team of Scientists and analysts to technically review data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots. The QC Specialist will communicate status updates on these activities to QC Management, Project Management, and QA to ensure that these activities meet project and production objectives on time.
The role will also support deviation investigations (OOS/OOT, etc) that occur within the QC laboratory. The QC Specialist will create, revise, edit, and prepare QC documents required for the functioning of the QC Analytical laboratory. This role will work cohesively with QC Management to ensure consistent delivery and execution of high-quality assay records and laboratory-related documentation.
Independently perform 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.
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. 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.
Accredited Bachelor’s degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x286 or (800) 927-9318 x286
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.