Title: QA Supervisor
Duration: Permanent
Pay:$70,000- $90,000
Location: Erlanger, KY
Shift: M-F 8-5pm
Key Responsibilities
- Provide routine on-site quality oversight of API warehouse operations, including receiving and quarantine, storage and segregation, environmental and temperature-controlled storage, order picking, packing, and shipment, returns and reverse logistics.
- Ensure warehouse activities comply with approved SOPs, GDP requirements, and regulatory expectations.
- Oversee and manage receiving records, Certificates of Analysis (CoAs), lot traceability records, and distribution documentation.
- Oversee and manage quality release activities for APIs prior to distribution, as applicable to the regulatory model.
- Author/Lead investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints
- Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs.
- Manage/Lead qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems.
- Author/Lead risk assessment activities related to storage, handling, and distribution activities.
- Collaborate with Quality Operations Program to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements.
- Serve as the quality operations management representative during FDA inspections and audits
- Lead/Support responses to audit findings and FDA Form 483 observations related to warehouse operations.
- Provide quality input into process improvements, capacity expansion, and business continuity planning.
- Support vendor oversight related to 3PLs, couriers, and transportation providers.
- Develop, track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc.
- Manage/drive continuous improvement initiatives to enhance compliance, efficiency, and reliability.
- Other duties as assigned
- Bachelor’s degree or a related discipline or equivalent experience may be considered.
- 6-10 years of quality experience in the pharmaceutical industry.
- 3+ years supporting warehouse, distribution, or GMP operations.
- Experience with API distribution, GMP/pharmaceutical warehousing, or 3PL oversight required.
- Hands-on experience with GDP and warehouse quality operations required.
- Strong working knowledge of:
- 21 CFR Parts 210 & 211, 21 CFR Part 11, ICH Q7, Q9, Q10
- GDP principles for pharmaceutical distribution
- FDA inspection expectations for API distribution facilities
- Data integrity and documentation practices
- DEA requirements for controlled substances (if applicable)
- Strong investigation, root cause analysis, and CAPA skills.
- Excellent communication skills for working with operations teams.
- Ability to work effectively in a hands-on, GMP warehouse environment.
- Proficient with QMS/eQMS systems and warehouse documentation
#IND-SPG
Estimated Min Rate: $70000.00
Estimated Max Rate: $90000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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