Posting ID: JP-002023922
This position supports the QC Analytical team for the Biologics Division and acts as the QC Equipment Coordinator.
How will you make an impact?
The Scientist I 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.
What will you do?
• 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
Additional Skills & Qualifications:
- High school degree required. Associates in a relevant scientific discipline preferred. Bachelor’s degree in Biology, Biochemistry or Chemistry seen as a plus.
- More than 1 year in the pharmaceutical or biopharmaceutical industry or experience as an equipment coordinator. Experience with SAP. Candidate job history should match daily responsibilities as close as possible.
Knowledge, Skills, Abilities
- Good organization and ability to work with a lot of different personalities in different departments.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072