Supervisor, QA Operations
3 weeks ago
The Supervisor, Quality Assurance Operations (2nd Shift) will lead a team that provides oversight of the manufacture, testing, and disposition of iPBMC (irradiated peripheral blood mononuclear cells). Responsibilities will include on-floor support to manufacturing staff, Batch Record review, and review of Quality Records such as Deviations.
This is a 2nd shift position working a 4-day week: Tuesday – Friday, 5pm - 3am
Responsibilities
- Supervise the QA Operations team (2nd shift) and help drive batch disposition by performing efficient reviews of records related to manufacture and testing
- Provide on-floor support to manufacturing staff, problem-solving or escalating issues as required.
- Support clean room readiness and release, and gowning qualification.
- Prepare and organize release documentation for Manager approval.
- Support investigations.
- Perform other duties as assigned.
Qualifications
- BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with a minimum of 3 years of relevant experience
- A background in cell culture, aseptic gowning and qualification, or ISO class 7 cleanroom operations is preferred.
- Good working knowledge of GMPs and cleanroom manufacturing
- Able to read, write and understand English, and be proficient in Microsoft Office (Excel, Word, Outlook).
- Excellent oral and written communication skills.
- Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
- Experience with use of an electronic QMS.
- Proficient with Microsoft Word, Excel, and PowerPoint.
Physical Requirements
- Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
- Able to wear cleanroom garments and personal protective equipment (scrubs, gowning coverall, masks, gloves, goggles).
- Able to see at near and mid-range with depth perception.
- Able to stand/sit/walk for long periods of time.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
*Salary will commensurate with experience
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Philadelphia, United States Planet Pharma Full timeThe Supervisor, Quality Assurance Operations (2nd Shift) will lead a team that provides oversight of the manufacture, testing, and disposition of iPBMC (irradiated peripheral blood mononuclear cells). Responsibilities will include on-floor support to manufacturing staff, Batch Record review, and review of Quality Records such as Deviations. This is a 2nd...
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