What are the responsibilities and job description for the QA Specialist position at Actalent Services?
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 cGMP, 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: $45.00 - $50.00 per hour
Schedule:
- 8 hour shift
Work Location: In person
Salary : $45 - $50
