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Form of workJob Description
JOB DESCRIPTION
• The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities
WHAT WOULD YOU CONSIDER TO BE THE TOP 3, NON-NEGOTIABLE SKILLS THAT YOU WILL BE LOOKING FOR HEN REVIEWING CANDIDATE RESUMES?
Communication Skills, Knowledge in Automation and Previous Experience in a similar position
Position is 100% onsite in Fort Washington, PA
- Schedule is 4, 10-hour days AND will include weekends
- Will train on 1st shift (6am-430pm), will work on 2nd (2pm-1230am) or 3rd (10pm-830am) shift
- Must have a Bachelors Degree
- Shop Floor exp
- This is a Quality Assurance role
- Will review Batch Records
- Conduct walk throughs on shop floor (daily, and monthly)
- Enusure Quality and Compliance are met
- Must have cGMP exp
- Help identify any issues to help correct in order to make more efficient
- Will provide support with Audits and SOPs
- Must have excellent Communication skills
- Be very detailed
- Should be a problem solver
- Automation environment exp
- SAP and LIMS is helpful
Update from Manager on the shift rotation:
- We are currently evaluating the schedule and may be making changes. I would like to stress that off shifts (2nd or 3rd) and weekends would be required.
- Our current schedule looks like this (3-week rotation and our work weeks end on Sunday)
3 week Rotations:
Mon-ON, Tue-OFF, Wed-ON, Thu-ON, Fri-ON, Sat-OFF, Sun-OFF
Mon-ON, Tue-ON, Wed-OFF, Thu-OFF, Fri-OFF, Sat-ON, Sun-OFF
Mon-OFF, Tue-ON, Wed-ON, Thu-ON, Fri-ON, Sat-OFF, Sun-ON
Must have GDP review exp
- Must have GMP exp
• The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities
WHAT WOULD YOU CONSIDER TO BE THE TOP 3, NON-NEGOTIABLE SKILLS THAT YOU WILL BE LOOKING FOR HEN REVIEWING CANDIDATE RESUMES?
Communication Skills, Knowledge in Automation and Previous Experience in a similar position
Position is 100% onsite in Fort Washington, PA
- Schedule is 4, 10-hour days AND will include weekends
- Will train on 1st shift (6am-430pm), will work on 2nd (2pm-1230am) or 3rd (10pm-830am) shift
- Must have a Bachelors Degree
- Shop Floor exp
- This is a Quality Assurance role
- Will review Batch Records
- Conduct walk throughs on shop floor (daily, and monthly)
- Enusure Quality and Compliance are met
- Must have cGMP exp
- Help identify any issues to help correct in order to make more efficient
- Will provide support with Audits and SOPs
- Must have excellent Communication skills
- Be very detailed
- Should be a problem solver
- Automation environment exp
- SAP and LIMS is helpful
Update from Manager on the shift rotation:
- We are currently evaluating the schedule and may be making changes. I would like to stress that off shifts (2nd or 3rd) and weekends would be required.
- Our current schedule looks like this (3-week rotation and our work weeks end on Sunday)
3 week Rotations:
Mon-ON, Tue-OFF, Wed-ON, Thu-ON, Fri-ON, Sat-OFF, Sun-OFF
Mon-ON, Tue-ON, Wed-OFF, Thu-OFF, Fri-OFF, Sat-ON, Sun-OFF
Mon-OFF, Tue-ON, Wed-ON, Thu-ON, Fri-ON, Sat-OFF, Sun-ON
Must have GDP review exp
- Must have GMP exp
