About the position
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 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 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 hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.
Responsibilities
- Independently manage project assignments.
- Ensure compliance with cGMP, regulations, and the Company's Quality Management System.
- Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents.
- 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.
- Make decisions guided by policies and procedures that impact the team's ability to meet performance objectives.
- Consult on complex decisions with next level manager.
- Execute critical site review and review of environmental monitoring data.
- Perform review of process simulation batch records.
- Perform Quality retain sample management activities.
- Lead Shopfloor audits to identify and address housekeeping and/or compliance gaps.
- Approve incidents and investigations related to deviation management.
- Assist cross-functional team with executing and approving change controls.
- Approve cleaning validation documentation as needed.
- May act as a Quality Risk Assessment Lead.
Requirements
- High school diploma with minimum four (4) years of experience in manufacturing, maintenance, laboratory, military environment, or related industry including two (2) years of experience in a GMP or FDA regulated industry.
- Bachelor of Science with minimum of two (2) years of experience in manufacturing, maintenance, laboratory, military environment, or related industry including two (2) years of experience in a GMP or FDA regulated industry.
Nice-to-haves
- At least one (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.
- 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.
