Associate Specialist, Quality Assurance

Job Description

The Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham within the Vaccine Manufacturing Facility while actively participating in and embracing an empowered team culture. The Shop Floor Quality Assurance Associate is responsible/accountable for Quality Assurance activities that support BCG manufacturing, including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including assessing product impact for events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and Reports.

Our Company recently constructed a new manufacturing facility to significantly expand its production capacity for TICE® BCG (BCG Live For Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. This facility will triple our current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

First (1st) Shift position. Monday thru Friday 6:00am to 2:30pm. Shift may require Weekends and Holidays.

Position Responsibilities:

• Reporting to the Quality Assurance Organization, will support project assignments for the shopfloor quality team.

• Provide QA shop floor support in the execution and review of GMP documentation such as product and cycle development, stability/engineering batches as well as other technical documents to meet schedule milestones.

• Provide QA shop floor support on batch review, alarm response, incursion response and deviation management.

• Provide QA shop floor support on Aseptic techniques, aseptic observations, cleaning techniques, and gowning observations.

• Partner with site functions to solve problems and achieve goals.

• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.

• Consults with peers and next level manager on more complex decisions.

• Is systematic, timely and appropriately rigorous when making important decisions

• Involves relevant stakeholders in a timely, appropriate manner.

• Proactively seeks out advice and information from others when addressing serious business issues that may impact other functions, geographies, etc.

• Draws accurate conclusions from reports, spread- sheets, and analyses to support decision-making.

• Always shares important and relevant information with the team.

• Develops strong networks and relationships across functions and other organizational boundaries.

• Demonstrates deep understanding of customers' or stakeholders' needs, requirements and expectations.

• Consistently delivers on commitments to customers and stakeholders.

• Continuously seeks new ways to improve the delivery of products and services to customers and stakeholders.

BUSINESS EXPERTISE:

• Basic awareness of management tools and systems to evaluate reports.

• Able to work with constituent groups include but not limited to internal customers (operations, technology and labs)

• Applies understanding and is able to anticipate the needs of customers with constituent groups to ensure product quality and timely resolution of issues.

• Utilizes monitoring, performance tools and systems to ensure product quality, drive Right First Time and compliance standards.

• Able to develop and sustain value-adding relationships with key customers using understanding of key relationships and their importance.

FUNCTIONAL EXPERTISE:

The Shop Floor Quality Assurance Associate role will be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing:

• Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters.

• Review of batch record documentation (electronic batch record comment resolution, autoclave records, review of electronic and paper batch records as applicable)

• Provide Quality oversight to alarm events (non-viable particles, different