Quality Assurance Compliance Specialist
3 days ago
Jubilant HollisterStier LLC, a renowned pharmaceutical and biopharmaceutical industry leader, offers a comprehensive range of services to support the development and manufacturing of innovative products.
The Allergy business is a global leader in the production of allergenic extracts, primarily focused on treating allergies and asthma.
Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials and lyophilized products.
The company is a proud member of the Jubilant Pharma family.
Our Commitment:
Caring, Sharing, Growing
We are dedicated to enhancing value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost-effectiveness, and wise investment of resources.
Work Schedule:
Monday - Thursday Nights - 6pm - 4:30am
Job Responsibilities:
The QA Compliance Associate/Senior Associate provides critical support to the company's Deviations, Corrective and Preventive Action (CAPA) program through a thorough assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues.
Ensure product compliance and product safety.
Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA, and vendor complaint activities.
Key Responsibilities Include:
- Review Deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs/Policies, Specifications, and related guidelines/regulations.
- Accountable for facilitating Deviation investigation/resolution, assessing product impact, and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
- Enter data into database in support of the corporate RCA and CAPA activities.
- Provide oversight of investigational RCA group activities, including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed-upon activities and tasks.
- Interface with management and responsible individuals to assure task completion on or before established due dates.
- Responsible for supporting quality systems, processes, and procedures (e.g., Deviation, CAPA, Vendor complaint, etc.) to assure compliance and product quality and safety.
- Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit, or regulatory inspections.
- Provide Deviation and CAPA metrics as needed in support of management review of system data.
- Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
- Sr. Associate (In addition to above): Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
- Speak to assigned deviations during regulatory and client audits.
- Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate).
- Perform special assignments as directed by the supervisor.
Qualifications:
Associate:
Associates Degree in Biology, Chemistry, or related field required. OR 5 years of experience may be used in lieu of an Associate's degree. Bachelor's Degree in a science field desired.
Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
Pharmaceutical and FDA regulated industry experience desired.
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