QA Specialist I – Plant Ops

RoslinCT US • Hopkinton, MA

1d • $52,000 - $76,000

About The Position

The QA Specialist I– Plant Operations is responsible for providing QA support and expertise to manufacturing plant operations. The ideal candidate also has experience with batch review and Lot Disposition, as well as Cell and Gene Therapy experience.

Requirements

• Minimum 2-5 years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing.
• Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
• Ability to partner cross functionally and provide quality support within agreed timelines to support plant activities
• Ability to work independently to meet objectives and timelines
• Ability to resolve issues and make decisions of low to moderate complexity independently and escalate complex decisions as needed.
• Versed in cGMP and ICH regulations / guidelines
• Strong verbal and written communication skills

Nice To Haves

• Cell Therapy experience preferred.

Responsibilities

• Create, Issue, and maintain batch records and labels.
• Review and approval of executed batch documentation
• Review and approval of GMP documentation such as, EM exceptions, Calibration/Work Order Records, equipment activation, various process-associated forms.
• Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
• Support product disposition, packout and shipping
• Provide QA review and approval of plant operations related procedures
• Promote quality culture among personnel

Benefits

• medical, dental, and vision insurance
• educational assistance
• a 401(k) program
• a variety of additional resources to help you thrive both personally and professionally.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed