- Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Performs approval of specifications and incoming inspections on material (i.e. drug, components) and distribution shipments.
- Performs process inspections, samplings, and audits as required.
- Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
- Author’s, revises, and complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
- Follows all Thermo Fisher Standard Operating Procedures.
- Performs all activities in a safe and efficient manner.
- Assures that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Other duties may be assigned to meet business needs.
- Associate’s degree
A minimum of 1 year of experience in Pharmaceutical or of a related, regulated industry and at least 2 years supervisory experience required.
- Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
- Must be able to work in a refrigerated environment (35F to 46F) with provided protective wear.
- Must be able to work in a freezer environment with provided protective wear.
- Must be able to work in potent compound suites with provided protective wear (PPE).
- Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
- Must be willing to work various shifts and overtime depending on business needs.
- Must be able to work independently.
- Must not be allergic to penicillin or cephalosporin products.
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- The employee must occasionally lift and/or move up to 20 pounds.
- Bachelor’s degree
- Proficient in Microsoft Office including Word, Excel, Access, and Outlook.Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.