Job Description
84211
**Please only local candidates to Devens MA
**Pharmaceutical experience is a MUST
Work Schedule is a 2 week rotation:
* 5am to 5:30pm, 2 on (Tue, Wed)
* 2 off (Thurs, Fri)
* 3 on (Sat, Sun Mon)
* 2 off (Tues, Wed)
* 2 on (Thurs, Fri)
* 3 off (Sat, Sun, Mon)
* Holidays included as the needs of the business warrant.
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Field Specialist QA Operations for a 12+ months contracting assignment.
Must have skills:
- Minimum 4 years relevant work experience, with experience in a Quality Assurance role
- Required manufacturing shop floor documentation experience
- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
- Understands continuous improvement and improves efficiency and productivity within the group or project
- Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
- Knowledge of US and global cGMP requirements
- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
Pay: $57-58/hour W2
Location: Devens MA
Responsibilities:
- Perform QA on the floor activities
- Ensure manufacturing compliance with applicable procedures and batch records
- Perform real time review of manufacturing batch records
- Review manufacturing shop floor documentation