- Applies Good Manufacturing Principles in all areas of responsibility.
- Applies Good Documentation Practices in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Performs approval of specification and incoming inspections on material (i.e. drug, components).
- Oversees operational processes for compliance.
- Performs in process inspection in manufacturing/packaging.
- Performs inspections of distribution shipments.
- Performs and writes deviations/complaints.
- Performs sampling as required.
- Corrects or escalates compliance concerns.
- Follows all Thermo Fisher Standard Operating Procedures.
- Performs all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
To perform this job successfully, the individual must be able to execute each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Prior experience in a regulated industry preferred.
Non-Negotiable Hiring Criteria:
- 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 on potent compound suites with provided protective wear.
- Proficient in Microsoft Office including Word, Excel, Access, and Outlook.
- Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
- Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
- Must be willing to work various shifts depending on business needs.
- Working weekday and weekend overtime may be required to meet business needs.
- Ability to learn the use of measuring tools such as micrometers and calipers.
- Must be able to work independently.
- Must not be allergic to penicillin or cephalosporin products.
Education/Experience - Two-year college degree or equivalent pharmaceutical/QA experience or equivalent combination of education and experience.
This position has not been approved for Relocation Assistance.