Manufacturing Quality Assurance Specialist | Integrated Production Team

Job Description

Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a Growth and Improvement minded Manufacturing Quality Assurance Specialist | Integrated Production Team that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Manufacturing Quality Assurance Specialist | Integrated Production Team provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model and with guidance from the IPT Quality Lead, ensures product quality process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system.

You will provide Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls and will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance.

Job functions are completed primarily on the production shop floor and in a team environment.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Completes batch release of supported products, this include release to Markets outside of the USA

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

• Assists in sending samples/lab reagents to release authorities

• Completes required SAP transactions to release product in SAP

• Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material

• Completes, reviews and sends release protocols to regulatory agencies

• Supports Regulatory inspections | Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors

• Provides coaching and mentoring of manufacturing supervisors and operators

• Conducts Quality review / approval of new and updated SOPs and CJAs

• 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

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

Education | Experience | Skills | Knowledge

Required Education: 

• Bachelor's degree*. Degree in life science, science discipline, 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 as described above, equivalent direct experience of minimum 1-2 years of work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturi