cGMP/ GDP/ Pharma Quality Analyst (ONSITE)

Overview

On Site
Depends on Experience
Contract - W2
Contract - 24 Month(s)
No Travel Required

Skills

Bachelors Degree
GDP review experience
GMP experience
Shop Floor experience
Quality Assurance experience
cGMP experience
Excellent Communication skills
Knowledge in Automation

Job Details

PLEASE DO NOT SUBMIT TECHNICAL QA RESUMES. ALL TECHNICAL QA RESUMES WILL BE REJECTED.

Please note that this is a 2 year contract 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
- Must have GDP review experience
- Must have GMP experience
- Shop Floor experience
- This is a Quality Assurance role
- Will review Batch Records
- Conduct walk throughs on shop floor (daily, and monthly)
- Ensure Quality and Compliance are met
- Must have cGMP experience
- 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 experience
- SAP and LIMS is helpful

- We are currently evaluating the schedule and may be making changes. Off shifts (2nd or 3rd) and weekends would be required.

- Current schedule looks like this (3-week rotation and 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

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

TOP 3 SKILLS:
Communication Skills, Knowledge in Automation and Previous Experience in a similar position

Applicants must provide their phone number. Reference job number A3992.