Onsite Biopharma QA Specialist (cGMP)

ACTalent; West Greenwich (RI); On-site; USD 34,000 - 41,000; Full time

Benefits offered by this job

Health benefits & dental/vision

401(k) plan

Pre-tax and Roth options

Life Insurance

Disability coverage

HSA

Transportation benefits

PTO

Job summary

Actalent is seeking a Plant Quality Assurance Specialist to provide on-the-floor quality oversight within a regulated biopharmaceutical manufacturing environment. This role partners with Facilities & Engineering, Process Development, Incoming Quality, Warehouse, and Manufacturing to ensure operations comply with cGMP and applicable regulatory standards.

The position includes reviewing and approving manufacturing records, MES and DeltaV trails, and managing deviations while ensuring proper

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biotechnology, Engineering, or a related field.
• Minimum of 2 years of experience in Quality or Manufacturing within a regulated environment.
• Strong understanding of cGMP principles and regulatory requirements.
• Experience reviewing GMP documentation, manufacturing records, deviations, work orders, or quality records.
• Experience with systems such as Maximo, MES, Veeva Vault, or similar quality/manufacturing systems preferred.
• Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Teams.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across Quality, Manufacturing, Engineering, and other technical teams.
• Ability to prioritize multiple responsibilities and make sound decisions in a fast-paced environment with limited oversight.

Responsibilities

• Provide quality oversight for Facilities & Engineering, Incoming Quality, Warehouse, Raw Material Sampling, Process Development, and Manufacturing activities.
• Ensure facilities, equipment, materials, processes, and products meet cGMP and regulatory requirements.
• Review and approve work orders and job plans within Maximo.
• Review GMP documentation, including logbooks, electronic and paper forms, pest-control documentation, and related reports.
• Review and approve Manufacturing Execution System (MES) records, including electronic batch records.
• Support the management and oversight of rejected materials.
• Review and approve DeltaV audit trail entries.
• Ensure deviations from established procedures are properly documented and handled according to approved quality processes.
• Collaborate cross-functionally to ensure quality-related activities and assigned tasks are completed accurately and on time.
• Proactively identify and elevate potential quality, compliance, or safety risks.
• Maintain required training and documentation to ensure continued compliance.
• Spend approximately 25% of the shift in cleanroom environments, following appropriate gowning and aseptic practices.

Skills

Quality oversight

cGMP knowledge

Regulatory compliance

Documentation review

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Tools

Maximo

MES

Veeva Vault

Job description

Actalent is seeking a Plant Quality Assurance Specialist to provide on-the-floor quality oversight within a regulated biopharmaceutical manufacturing environment. This role partners with Facilities & Engineering, Process Development, Incoming Quality, Warehouse, and Manufacturing to ensure operations comply with cGMP and applicable regulatory standards.

The position includes reviewing and approving manufacturing records, MES and DeltaV trails, and managing deviations while ensuring proper