Quality Assurance Lead – Environmental Monitoring & Quality Systems
At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health.
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 overseeing: 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 ensures the team meets the deadlines outlined in those plans. In order to maintain deadlines, the 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 the company’s mission globally.
- Will liaise and communicate with Quality assurance, Quality control, and Validation department regarding any changes or improvements in QMS or regular day-to-day duties.
- Take part in internal audits 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
Why We Do What We Do
At Wedgewood Pharmacy, your work has purpose. Every prescription you help prepare, support, or deliver contributes to improving the health and well-being of animals. We are passionate about what we do and proud to build a workplace where people feel supported, included, and valued.
Our Commitment to Inclusion
Wedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.
As published by greenhouse
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
- Preferred First Name optional
- Address 1 optional
- Address 2 optional
- City optional
- State choose one · optional
- Zip Code optional
- Pay Expectations Aligned choose one
- Will you now or in the future require sponsorship for employment work authorization? choose one · optional
- Currently, or in the future, does your authorization to work in the United States involve Curricular Practical Training (CPT) or Optional Practical Training (OPT)? choose one
- Are you at least 18 years old or older? choose one
- Are you a high school graduate, or have you earned a GED? choose one · optional
- I acknowledge that Wedgewood participates in E-Verify meaning Wedgewood will provide the federal government with my Form I-9 Emloyment Eligibility Verification to confirm that I am authorized to work in the United States. E-Verify is completed for all hires after offer acceptance. For more information, please visit the e-verify.gov website for an overview of the process. choose one · optional
- Have you ever had a professional license denied, revoked, suspended, or otherwise restricted, conditioned, or limited or have you surrendered a professional license, been fined, placed on probation, reprimanded, disciplined, or entered into a settlement with a licensing authority in connection with a professional license you have held in any jurisdiction, or is any such action pending? choose one
- Have you at any time had an application for registration with the Drug Enforcement Agency (DEA) denied, had a DEA registration revoked, or surrendered a DEA registration for cause? choose one
- Are you available to work the hours as stated in the job posting? choose one
- Are you able, at the time of employment, to submit verification of your legal right to work in the United States? choose one
- Which regulatory guidelines (e.g. FDA, EMA, ICH, etc.) do you have the most experience navigating? written answer
- How do you ensure your team stays updated on compliance changes? written answer
- Do you have experience managing or participating in cGMP regulations? choose one · optional
- Explain how you managed an adverse out-of-specification or out-of-tolerance event. written answer
- How have you fostered a “quality-first” culture across an organization, especially when facing tight production deadlines or pushback from other departments? written answer
- Describe your experience with Environmental Monitoring programs. What types of sampling have you performed or managed? written answer
- Describe your experience with Document Control and Training Systems written answer
- Please tell us why you consider yourself a suitable candidate for this position. You should include examples of proven skills and relevant talents you would bring to this position. Also, include your motivation for seeking this position. written answer · optional
- List any additional information you feel may be helpful to us in considering your application (e.g. professional trade, civic activities, and/or offices held). written answer · optional
- By selecting YES I consent to receiving recruiting SMS messages from Wedgewood Pharmacy at the phone number provided above. choose one
- Have you previously interviewed or worked for Wedgewood Pharmacy or any of its affiliates? choose one
- Are you willing to relocate to Albany, Ohio if you do not reside locally? choose one