Lead Operator
MedPharm
Durham, NC, USA
Posted on Tuesday, October 1, 2024
Summary of Key Responsibilities:
Required Qualifications and Skills:
- Operate manufacturing equipment and instruments.
- Complete assigned tasks in a timely manner.
- Conduct daily activities in an organized, efficient manner.
- Perform simple, routine, complex, and critical operations.
- Troubleshoot equipment issues, when necessary.
- Ensure process equipment is appropriately maintained for operation.
- Perform and document operations in accordance with cGMP’s.
- Execute equipment qualification protocols and validation protocols.
- Routinely draft and revise standard operating procedures and master batch records.
- Recognize and initiate process deviations.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Communicate effectively, both in written and verbal formats.
- Maintain training compliance.
- Ensure a safe working environment for all staff.
Required Qualifications and Skills:
- A.A.S. in a scientific discipline, or equivalent experience preferred.
- 3-5 years’ experience in a cGMP biopharmaceutical manufacturing environment required.
- Experience training/mentoring staff is a MUST! No direct reports.
- Must be able to work within and adapt to electronic systems.
- Able to work in an intense, fast-paced work environment.
- Able to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
- Able to work independently and as part of a team.
- Must be able to read, write and converse in English.
- Must have a good working knowledge of MS Office (Outlook, Word and Excel).