Analyst 2 - Fort Washington, United States - eTeam

Description

Schedule:
Will train on 1st shift (6am-430pm), will work on 2nd (2pm-1230am) or 3rd (10pm-830am) shift Schedule is 4, 10-hour days AND will include weekends Would like to stress that off shifts (2nd or 3rd) and weekends would be required


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 Details: - Must have GDP review exp - Must have GMP exp - 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 Top 3 skills: Communication Skills Knowledge in Automation Previous Experience in a similar position

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