Specialist, Quality Assurance 1st shift

Job Description

Our Company constructed 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 Companys longstanding commitment to producing this medicine for the patients who need it. The facility will include endtoend 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 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 substance media preparation and sterile supply. The candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operations of pharmaceutical biologic and/or vaccine manufacturing facilities. The successful candidate must be able to examine issues from diverse perspectives provide a handson approach to problem solving and be selfmotivated to identify and lead process improvement projects.

Position Responsibilities Could Include:

• 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 Companys Quality Management System.
• 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 teams ability to meet performance objectives.
• Consults on an asneeded basis with next level manager on more complex decisions.
• Executes critical site review and review of environmental monitoring data.
• Perform review of process simulation batch records.
• Perform Quality retain sample management activities if applicable.
• Lead Shopfloor audits to identify and address housekeeping and/or compliance gaps.
• May approve incidents and investigation related to deviation management.
• Assists crossfunctional team with executing and approving change controls.
• Approve cleaning validation documentation as needed.
• May act as a Quality Risk Assessment Lead.

Education Minimum Requirement:

High School Diploma or equivalent

Required Experience and Skills:

Minimum four (4) years of experience in manufacturing maintenance laboratory military environment or related industry including two (2) years of experience in an GMP or FDA regulated industry.

Schedule: Monday Friday 6:00 AM 2:30 PM EST (will include weekends and holidays to support project work).

Preferred Experience and Skills:

• 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 fastpaced complex environments and escalate appropriately.
• 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.
• Demonstrated interpersonal skills including flexibility and collaboration.
• Demonstrated analytical aptitude critical thinking skills and problem solving.
• Demonstrated ability to upskill others.
• Demonstrated verbal and written communication skills.
• Experience in pharmaceutical related environment.

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