- 190484 - QC Scientist I
- St. Louis
- Up to $29.32 DOE
- 4 mos
- Chipton-Ross is seeking a QC Scientist I for an opening in St. Louis, MO.
The Scientist I (QC Equipment Coordinator) position will serve as a liaison between the QC group, TFS Engineering group, clients and vendors. The person will be responsible for following Current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to QC Equipment commissioning , maintenance and decommissioning activities, scheduling and planning.
Manage service and maintenance of all QC-owned equipment. Schedule all service for equipment, coordinating with contractor, service provider of TFS metrology group, including but not limited to PM scheduling, calibration. Asset management – commissioning of new QC equipment, removal and/or disposal of all QC-owned equipment that needs to be decommissioned. Build spreadsheets and other tools to accurately and efficiently track assets and scheduled equipment PMs. Follow up with QC management, TFS metrology, Engineering, contractor or service provider to ensure all work has been performed. Field repair calls, coordinate repair needs and negotiate and payment for all service performed and escort field service technicians on site, as needed. Prepare and maintain service records for QC equipment. Manage QC equipment commissioning program - including tracking of timelines, scheduling inter-departmental (Validation group, Metrology, Engineering, etc) meetings, providing update reports to QC management, and clearly communicating timeline risks and challenges. Coordinates with QC management on the evaluation of changes in the validated/equipment laboratory equipment, selection or evaluation of new equipment, and approving new or modified. Calibration/PM criteria that impact the safety, identity, strength or quality of the product. Reviews the calibration/verification or PM data to ensure that the equipment is calibrated according to predetermined schedules and procedures. Independently writes and edits SOPs, Change controls, project plans, equipment calibration/PM procedures, and validation IQ/OQ protocols. Other duties within the quality department as required. Responsible for simple equipment administrator functions. Scheduling, technically completing PMs and work orders in SAP. Generating and processing paperwork for equipment changes in SAP.
At least 1 year related experience in biopharmaceutical or pharmaceutical industry or equipment coordinator activities. Knowledge of 21 CFR210/211. Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. Routine use of MS Excel, MS PowerPoint, MS Project, MS Word and SAP is essential. Strong written and oral communication skills. Highly organized with attention to detail. Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables) Strong organizational skills in monitoring QC equipment activities in progress. Excellent communication skills - Coordinate and communicate with QC management, Metrology, Facilities, Supplier Quality, Validation, IT, Engineering, Manufacturing, Contractor, service provider for QC equipment- related needs and issues. Working knowledge of cGMPs and Quality Control regulatory requirements. Knowledge of equipment used in a Quality Control laboratory – spectrophotometers, balances, pH meters, density meters, HPLCs/UPLCs, plate readers, computers, pipettes, and thermometers
Accredited Bachelors Degree in a Biological Science or Engineering related field (Biology, Biochemistry or Chemistry preferred).
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 x340 or (800) 927-9318 x340
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.