QA Specialist Position Available In Middlesex, Massachusetts

QA Specialist (part of Allegis Group) 3.5 3.5 out of 5 stars 1 1st Ave, Waltham, MA 02451

Responsibilities:

Responsibilities include but are not limited to:

• Provide quality on-the-floor support of manufacturing on critical operational days and onsite support of non-critical manufacturing days, reviewing documentation and providing real-time support of manufacturing issues etc.
• Support quality decisions that may impact operations ensuring appropriate escalation to management.
• Support the identification, evaluation and mitigation of risks and communication of gaps for quality and GMP processes.
• Initiates and assists in investigations of Quality Systems documentation (deviations, change controls, CAPAs, Out of Specifications/Tolerances etc.)
• Authors and reviews SOPs, Work Instructions and Forms to ensure compliance and adherence to regulations/cGMP operations.
• Collaborates with Manufacturing and Quality Control to resolve equipment and process/testing issues.
• Ensuring adherence to cGMP and GDPs across the organization
• Provide support for internal and external audits including report generation
• Support activities for various project(s) to ensure that the project timeline/schedule is met

Requirements:

• BS degree in a relevant scientific discipline required, at a minimum.
• 3-5+ years of relevant biotech/pharma industry experience, with at least 3 years combined of relevant experience in Aseptic GMP manufacturing Operations and Quality Assurance covering GMP manufacturing operations.
• Experience with supervising/managing direct reports
• Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements.

Successfully managed inspections by major Health Authorities (e.g., US

FDA, EMA

).

• In-depth knowledge of c

GMP, FDA

regulations (21 CFR Parts 211, 212), and ICH regulations. In depth knowledge of QC regulations.

• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity.
• Strong data tracking, trending, and analysis skills.
• Strong communications skills, a team player who can lead, mentor, and inspire others
• Gene or cell therapy product experience preferred
• Demonstrated success in delivery of key milestones against tight timelines

Job Type:

Full-time Pay:

$37.00 – $45.00 per hour Expected hours: 40 per week

Schedule:

8 hour shift Day shift

Work Location:

In person