What are the responsibilities and job description for the Field QA Specialist – GMP Manufacturing (Onsite– Devens, MA) position at Stage 4 Solutions?
We are seeking a Field QA Specialist for a global pharmaceutical client. You will be responsible for quality activities for the LSCC accordance with client policies, standards, procedures, and Global cGMP.
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role at the client’s office in Devens, MA. Work Schedule: 2 week rotation as detailed here:
Responsibilities
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $58/hr - $61.34/hr
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role at the client’s office in Devens, MA. Work Schedule: 2 week rotation as detailed here:
- 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.
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.
- 4 years of experience required in manufacturing shop floor documentation
- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must have sound knowledge and experience in US and global cGMP requirements. FDA-regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Understands continuous improvement and improves efficiency and productivity within the group or project.
- Equivalent combination of education and experience might be acceptable.
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $58/hr - $61.34/hr
Salary : $58 - $61