QA Auditor Supervisor I​/II

Company Overview

Jubilant Hollister Stier LLC, Spokane’s Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant Hollister Stier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma.

Jubilant Hollister Stier is a proud member of the Jubilant Pharma family.

Our Promise:
Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.

The QA Supervisor of Auditing reports in through the QA Commercial Manager and oversees the QA Auditing team with the goal of ensuring that finished goods meet necessary quality standards. This department provides QA auditing of internal manufacturing operations to ensure that all products produced meet labeling, dating and packaging requirements as defined by Standard Operating Procedures and GMP. This position provides direction and support of the daily operations in the QA Auditing department through scheduling and assignment of tasks among the QA Auditing team.

The individual in this position will establish and maintain a program to ensure the appropriate training and documentation of training of QA Auditing team (including safety, cGMP, and job functions). Additionally, the individual in this position will also be responsible for providing supervisor oversight for the QA Auditing team, including conducting performance evaluations of that staff. The individual in this role will establish and maintain standard operating procedures and records associated with the inspection finished goods.

• Supervise and assist QA Auditing team with resolution of issues and determine appropriate priority setting. Schedule department resources and shift coverage as needed.
• Assure corrections of labeling, expiration date, batch identification, packaging components, and bulk finished products through careful visual inspection and comparison to Batch Manufacturing Records.
• Review completed inspection records and entries for completeness and accuracy. Make disposition recommendations as appropriate of completed QA Auditor inspection records.
• Assure through a system of auditing that Good Manufacturing Practices are followed in manufacturing and finished product packaging areas.
• Recognize potential problems and/or document problems encountered, following up with department supervisors to assure corrective actions are taken to resolve any deficiencies in product quality or manufacturing systems and procedures.
• Create and/or maintain standard operating procedures and procedures for QA auditing department.
• Issue Incidents and perform investigations for Incident reports.
• Assure appropriate training of new and backup QA Auditors. Assure department personnel are current on all applicable qualification and master inspection sets.
• Qualify and control Master Inspection Sets.
• Complete Performance Reviews for each direct report including objective setting.

• Maintain appropriate staffing levels and supervise performance of direct reports. Engage in recruiting, coaching and recognition activities.
• Develop and maintain methods of measuring group metrics.
• 2-3 years of supervisor experience desired.

• Associates Degree Required
• Bachelor’s Degree Desired
• 5 years of related experience can be used in lieu of a degree.
• 5 or more years of related experience desired.
• Advanced vocational/specialized knowledge required
• Working Knowledge in Microsoft Word and Excel required, PowerPoint desired.
• This position requires knowledge and interpretation of GMP’s and quality systems. The applicant should be able to identify deficiencies in documents and propose changes.
• This role is required to be able to review vendor…