Field QA Specialist - Pharma Onsite Devens MA

We are looking for a Field QA specialist for a Global pharmaceutical Company. You will be responsible for quality activities for the Single Use Facility in accordance with the clients policies standards procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records providing realtime review of manufacturing batch record documentation and logbooks and working with operations to resolve manufacturing issues.

This is a 40hour perweek 12month contract (extensions possible) 100% onsite role in Devens MA (The candidate must be able to work onsite 5 days a week). The shift for this role is Monday through Friday 2 pm 10:30 pm.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

• Perform QA on the floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.

• Perform realtime review of manufacturing batch records.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Develops and revises procedures.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Review manufacturing shop floor documentation.

Requirements:

• 4 years experience in a Quality Assurance role in an FDA regulated environment

• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Knowledge of US and global cGMP requirements.
• Must have sound knowledge and experience in FDAregulated cGMP warehousing Quality and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• 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.
• Must have strong authorship and ability to critically review investigations interpret results and generate technical conclusions consistent with Quality Risk Management principles.

Please submit your resume to our network at (please apply to the Field QA Specialist Pharma (Onsite Devens MA)role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equalopportunity 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: $55/hr $59/hr.