Specialist, Quality

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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). 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 and Technology to enable RFT production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements.

The Quality Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance, and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the IPT. The Quality Specialist performs job functions primarily on the production shop floor in a team environment.

Primary Responsibilities

• Quality batch record review and approval

• Quality review and approval of master batch record updates

• Critical site reviews for per process environmental monitoring

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

• Quality review and approval of new and updated SOPs and Controlled Job Aids

• GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements

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

• Actively participates in the Tier process and uses this forum to escalate concerns and best practices

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

Education Minimum Requirement

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

Required Experience and Skills

• Minimum two years of relevant post-degree work in a laboratory, manufacturing, or quality position

• Evidence of leadership skills coupled with good verbal 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

• Familiarity with GMP documentation review is a key skill necessary for success in this position

• Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas

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 eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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