Quality Assurance Lead – Environmental Monitoring & Quality Systems

We are seeking a Quality Assurance Lead to join our team in Albany, Ohio. This position reports to the Quality Assurance Manager.

You will be primarily responsible for the environmental monitoring program, document control management, and training. Experience in Environmental Monitoring; specifically, performing or overseen: Viable Air Sampling, Non-Viable Particulate Monitoring, Surface Monitoring, Personnel Monitoring, Trend Analysis, Excursion Investigations (OOS) and Environmental Monitoring Reporting . Experience with Quality Systems, Including: Change Control, Deviations, CAPAs, Document Control, Training Systems, Risk Assessments and Internal audits. Prefer Regulatory experience: FDA 21 CFR 210, 211, 21 CFR Part 11, FDA Aseptic Processing Guidance, USP <787>, USP <800>, 503B Outsourcing Facility Guidance

The Basics

Location: Albany, Ohio
Job Type: Regular Full-Time
Schedule: Monday–Friday, 6:00 AM–2:30 PM
Compensation: $55,000 - $65,000

How You’ll Make an Impact

• Actively seek to resolve any concerns while adhering to the company policy and standards of behavior
• QA lead is responsible for leading his/her team. This often involves resolving conflicts between individual team members or even between different teams.
• QA lead will also mentor his/her team and motivate them during both the stressful times and the slow times on the job.
• QA lead will define strategies to ensure the product being released is up to industry and company standards.
• QA lead creates plans, including individual phases, and ensure the team meets the deadlines set forth in those plans. In order to maintain deadlines, QA lead will also evaluate the team throughout to identify areas where improvement can be made.
• Will support compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
• Will be responsible for compiling and reporting monthly metrics related to quality systems.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations and facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally.
• Will liaise and communicate with Quality assurance, Quality control, Validation department in regard to any changes or improvements in QMS or regular day to day duties.
• Take part in internal audit as well as any risk assessment. QA lead identifies risk and creates plans to mitigate it. QA leads also hold regular team meetings to identify new risks and create new mitigation plans on the fly. Leads also encourage their team members to do the same.

What We're Looking For

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Animal Sciences, or related scientific discipline
• Minimum 3-5 years of experience in FDA-regulated pharmaceutical, medical device, biologics, sterile compounding, or other cGMP-regulated environments
• Experience in Animal Science or food industry is highly desirable
• Strong knowledge of quality systems (Quality Planning, Management Review, Internal Audit, CAPA, Document Controls, etc.)
• Experience analyzing company needs and ability to effectively organize and manage multiple company initiatives and encourage coworkers to do the same
• Proficient using Microsoft Suite and other data entry software
• Strong understanding of business goals and standards for customer service
• Extensive knowledge of management strategies and practical application in the workplace

What You’ll Love About Wedgewood

• Competitive compensation and benefits
• Opportunities for growth and career development
• A supportive, team-first culture where your work matters
• The ability to make a real impact on animal health every day