Specialist, Quality Assurance

Job Description

Position Description:

Specialist, Quality Assurance

Our Company will construct a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

The Quality Assurance Specialist will support this expansion. Project activities requiring support include the capital project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product.  The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.

Position Responsibilities:

• Reporting to the Quality Assurance Organization, will independently manage project assignments.

• Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.

• Supporting areas such as Design, Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizers, etc.).

• Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and 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 on an as-needed basis with next level manager on more complex decisions.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline.

• and/or Master’s Degree (or other advanced)

Required Experience and Skills:

• With Bachelor’s Degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.

• With Master’s (or other advanced) degree, at least 1 years of experience in the pharmaceutical industry or highly regulated industry.

• At least 1 year of experience in aseptic manufacturing or other clean room environment .

• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.

• Effective decision making, problem solving and communication skills.  Ability to manage multiple priorities.

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

• Schedule: Monday - Friday, 2:00 PM - 10:30 PM EST (will include weekends and holidays to support project work).

Preferred Experience and Skills:

• GMP quality experience with biological drug substance or drug product.

• GMP experience with qualification of equipment.

• Experience with Quality Risk Management.

• Project Management experience in a highly regulated industry.

• Experience with Kneat, SAP, Veeva and/or GLIMS.

• Experience in deviation management with focus on quality review and approval.

• Experience in Aseptic processing, aseptic observations, and techniques.

• Electronic manufacturing batch records (eMBR) experience.

NOTICE FOR INTERNAL APPLICANTS

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