Lead Associate, QA Compliance

About the role

Jubilant HollisterStier LLC is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts. As part of the Jubilant Pharma family, we are committed to enhancing value for our customers and stakeholders through innovation, efficiency, and wise resource management.

Responsibilities

• Support the company Deviations, Corrective and Preventive Action (CAPA) program through Root Cause Analysis (RCA) of deviations and vendor complaints/issues.
• Affirm product compliance and product safety.
• Ensure accurate and timely data entry and oversight of Quality Systems related to Deviations, CAPA, and vendor complaint activities.
• Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs/Policies, Specifications, and related guidelines/regulations.
• Facilitate deviations investigation/resolution, assess product impact, and complete/write 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.
• Support quality systems, processes, and procedures (e.g., Deviations, CAPA, Vendor complaint, etc.) to assure compliance and product quality and safety.
• Assist QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
• Provide deviations 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 processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
• Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
• Speak to deviations during regulatory and client audits.
• Aid in reviews and approvals of minor deviations in the QMS system.
• Aid in RCA chart review for the QAC team members.
• Act as QA SME on Change Control records within the QMS.
• Provide leadership and guidance to QAC team members.
• Report performance issues to QAC supervisor as they arise.
• Act as QA Compliance Supervisor when requested by the QA Manager (in the absence of the supervisor).

Qualifications

• Associates Degree in Biology, Chemistry, or related field required.
• Bachelor’s Degree in a science field desired.
• 5 to 10 years related experience required with an Associate’s Degree required.
• Minimum of 3 years related experience required with a Bachelor’s Degree required.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Lead and Supervisory experience desired.
• Ability to lift 30 pounds unassisted required.
• Microsoft Word & Excel experience required.
• Knowledge of cGMPs desired.

Pay & Benefits

Hiring Wage: $77,969.00 – $101,200 annually depending on experience, with opportunity for growth, promotion, and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role.

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Schedule

Weekday Nights, Monday-Wednesday E/O Thursday 6pm-6am

Contact

If you require assistance applying for a position, please contact our HR Department at: JHS-TalentAcquisition@jubl.com