Tech II, QA Rec Retention

About the role

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family.

Responsibilities

• Maintain and perform administrative functions in various Records database types, i.e. LUMAC Database, Access Database, Librarika Database etc.
• Accurate and consistent maintenance of these digital systems are crucial to document retention and accountability, support for Client and Regulatory audits, support for Compliance investigations, and high-volume review requests.
• Receive, account for, digitally/physically locate, and systematically house Manufacturing controlled documents, Quality documents, and facility records in a controlled access area in accordance with established format determined by record type on a daily basis.
• Coverage of off-site records, including scanning all CMO batch records for QA Release department with an organized and methodical approach, ensuring they meet standards for Release/Client Review.
• Manage retention sample areas that adhere to the proper storage conditions; receive and process daily, monthly and annual requests for sample review.
• Coordinate and effectively communicate with QA Compliance to review and process client complaints and pull appropriate APRs for Annual Product Review.
• Support Manufacturing with document requests to drive timely closure of Investigations, PRs, CAPAs and Change Controls.
• Coordinate and effectively communicate with the QA Document Systems Manager in support of client and regulatory audits, providing requested documents quickly and efficiently.
• Manage Quality shred bins for the weekly destruction of discarded documents via contracted third party.
• Initiate, revise and serve as collaborators on department SOPs as needed.
• Provide investigation support and RCA (Root Cause Analysis) input for deviations and CAPA events.

Qualifications

• High School Diploma or Equivalent required.
• Associates of Arts or Science preferred.
• 2-3 years related experience required.
• Must possess excellent computer skills required. Must have proficiency with MS Word, Excel required.
• FDA Regulated Industry Experience preferred.
• Must possess excellent computer skills and understanding of computer technology in order to input information into various programs required.
• Microsoft Word and Excel required.
• Adobe Acrobat knowledge required.
• Proficiency in spelling, punctuation, and grammar are desired.
• Basic exchange of information. Managing conflict and influencing outcomes desired.

Benefits

Starting on your first day, you receive: Medical, Dental & Vision coverage Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D Insurance Short-Term & Long-Term Disability Insurance Employee Assistance Program

Pay

Hiring Wage: $25.12– $33.97 TO INCLUDE SPECIFIC SHIFT DIFFERENTIAL, with opportunities for growth, promotion, and annual raises.

Schedule

On Site, Full-Time