Quality Specialist - Integrated Product Team

Job Description

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team) operating model. The Quality Specialist, with guidance from the IPT Quality Leader, ensures product/process quality, represents Quality on the shop floor, ensures adherence to Good Manufacturing and Documentation Practices, and completes quality checks and SAP transactions required to release product. The Quality Specialist performs 100% process document/logbook audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT). He or she provides support directly to the production floor, to include oversight for adherence to cGMPs, RFT completion of production GMP documentation, and effective investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor, collaborating with Operations, Laboratory Operations and Technology to enable RFT production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements.

• Becomes fully trained in relevant Standard Operating Procedures (SOPs).

• Learns cGMPs, the manufacturing process, laboratory operations and our Company quality systems, including SAP, LIMS and electronic logbook, laboratory data, and batch record platforms.

• Review/Approval of documentation within the IPT to ensure compliance with cGMPs and regulatory requirements.

• Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.

• Performs shop floor audits to support compliance.

• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.

• Author/Approval SOPs and job aids.

• Foster a customer service attitude within the E2E.

• Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates.

• Deviation Management and Change Control assessments and approvals.

• Assists with training of incoming personnel and ensures compliance with departmental procedures.

Education:

• Bachelor's degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.

• In lieu of Bachelor’s degree, equivalent direct experience of 4 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.

Required Skills:

• At least two years of relevant post-degree work experience in a laboratory, manufacturing, or quality position.

• Evidence of leadership skills coupled with good oral and written communication skills.

• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Preferred Experience and Skills:

• Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas.

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.

• Demonstrated ability to upskill / coach others.

• Strong written and verbal communication skills.

• Familiarity with vaccine and/or pharmaceutical processing.

• Familiarity with batch documentation review and/or shop floor auditing programs are a strongly preferred skill necessary for success in this position; prior experience in those areas is a plus.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer el