Biopharmaceutical Manufacturing Associate II
Performs all production operations in the area of assignment within the Rockville Biopharm Manufacturing facilities. Duties include: preparation of buffers and medias and/or assemblies, following written procedures and batch records. Operate process equipment such as tanks, CIP/SIP skids, agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment following a high standard of GMP compliance and SOP and BRs as written. Support campaign start-up/changeovers/tech transfer activities and perform production operations in areas assigned.
- Ability to perform assigned tasks and follow instructions
- Perform process steps in coordination with other associates. Asks for help and does not perform steps without proper training/qualification.
- Adheres to scheduling changes and responds appropriately.
- Performs production operations following written SOP's/BR's in accordance with cGMPs, with minimal/no variance.
- General knowledge of cleanliness and bioburden control techniques (aseptic process)
- Frequent communication with area supervisor when work requests are needed and may initiate requests. Communicates any shifts in process parameters.
- Gives input/makes suggestions to improve process.
- May revise BR or SOPs/Work instructions as assigned
- Follow all cGMP's and EHS procedures.
- Communicates EHS issues to team members and supervisor.
- Attends and completes all mandatory training(s).
- Ensure training plan is accurate and up-to-date.
- Always ensures trainer is present as you learn new process steps/equipment.
- Must demonstrate GSK values and behaviors at all times
- Must be reliable and able to perform process steps in coordination with team members.
- Prepares and participates in area readiness for internal and external audits.
- Becoming familiar with the technical issues in the area. May assist others in troubleshooting activities as assigned.
- Complies with GMP and EHS procedures and policies.
- Works well with people in other areas and with team members.
- Works with other associates to carry out daily tasks accurately
- Becoming familiar with technical issues in the area. May assists in trouble shooting activities
- Works closely with other team members under supervisor directions.
- Provides reliable process support and works alongside others, completes performer/verifier steps under the supervision of more senior personnel or supervisor.
- Meets industrial excellence or personal metrics as part of department goals.
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