QA Specialist, Drug Product

What You'll Do

• Supports the development of documents, processes and procedures for the Drug Product program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state from startup into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation including risk and impact assessments, product and process equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans and validation summary reports.
• Generates, reviews and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
• Generates, reviews and approves QA documentation, procedures and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP regulated facility.
• Ensures the fulfillment of project and operational quality objectives within desired timelines.
• Provides Manufacturing shop floor support including Acceptable Quality Limit (AQL), critical process step verification, issue resolution, line clearance and alarm response.
• Participates in optimization or improvement initiatives; supports regulatory agency and third-party inspections.
• Performs other duties, as assigned.

Knowledge, Skills, Or Abilities

• Excellent verbal and written communication skills to partner with different teams and stakeholders; fluency in English.
• Strong time management; ability to meet tight deadlines to ensure effective prioritization of tasks.
• Critical thinking and superior problem-solving skills.
• Collaborative attitude; willingness to work with global peers and cross-functional teams toward company and department goals.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Ability to fully embrace a Genki culture and bring positive energy to a dynamic work environment.
• Flexible to support a 24/7 manufacturing facility.
• The position also has occasional opportunities for international and/or domestic travel.

Minimum Requirements

• Bachelor's degree in Life Sciences, Engineering or equivalent with 2+ years of applicable industry experience; OR,
• Master's degree in Life Sciences or Engineering with 0+ years of applicable experience.
• 1+ years of experience working in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Preferred Requirements

• High level understanding/familiarity of validation of production equipment, hygienic utilities, quality systems, automation, methodologies, manufacturing and IT Systems.
• Understanding of GAMP5, Data Integrity and application of 21 CFR Part 820 and Part 11.
• Understanding of formulation, aseptic filling and/or visual inspection.
• Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, Veeva, Kneat validation software, and/or PAS-X.
• Experience with startup Projects or initiatives.

Working Conditions & Physical Requirements

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time, up to 120 minutes.
• Ability to sit for prolonged periods of time, up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environment, 2-8 degrees C.