Quality Assurance Specialist

Job Description Key Responsibilities Material Quarantine & Inventory Control (Primary Focus)

• Manage quarantine for raw materials, packaging, bulk, and finished goods
• Ensure proper storage, system controls, and status accuracy
• Support material release, rejection, or rework decisions
• Partner with Warehouse, Manufacturing, and QC on inventory status
• Investigate discrepancies and monitor aging materials
• Ensure compliance with cGMP and internal procedures

• Lead or support deviations, nonconformances, and OOS investigations
• Perform root cause analysis (5-Why, Fishbone, etc.)
• Create and track corrective and preventive actions (CAPAs)
• Ensure timely, thorough, and compliant investigations
• Monitor trends and recommend improvements

• Assist with change control and quality impact assessments
• Support complaint investigations and trending
• Maintain SOPs and quality documentation
• Support training compliance and documentation review
• Monitor quality metrics and participate in risk assessments

• Conduct internal audits
• Support external audits (FDA, customers, third-party)
• Prepare documentation for inspections
• Assist with audit responses and CAPAs
• Promote ongoing inspection readiness

• Review batch records for accuracy and compliance
• Identify and correct documentation errors
• Issue and track controlled documents
• Support batch release activities

• Provide QA support on the production floor
• Review and approve logs and controlled forms
• Support validation activities (IQ/OQ/PQ)
• Assist with product release and regulatory documentation
• Participate in continuous improvement initiatives

• Bachelor's degree in Life Sciences, Chemistry, or related field (preferred)
• Equivalent experience may be considered

• 4-7 years in Quality Assurance in a regulated manufacturing environment
• Experience with quarantine, investigations, and CAPAs
• Knowledge of FDA cGMP (21 CFR 210/211)
• Experience with audits and ERP/QMS systems (e.g., SAP)

• Strong knowledge of cGMP and quality systems
• Problem‑solving and root cause analysis
• Attention to detail and documentation accuracy
• Ability to manage multiple priorities
• Strong communication and teamwork
• Ability to work independently

• Stewardship: We continuously improve the safety of our people and products, and we protect the planet by innovating solutions to reduce our environmental impact.
• Passion for Problem Solving: We listen to our customers and actively work to find solutions for unique situations. We think creatively to innovate and seize opportunities that will drive growth and make all our customers' and consumers' lives better.
• Empowerment: We encourage and lead our people to be accountable by equipping them to make decisions and own the outcome.
• Expertise: We create innovative solutions and partnerships that are relevant to service our communities and customers.
• Doing the Right Thing: We expect our people to understand ethical boundaries and be inclusive of other backgrounds, ideas, and perspectives. Demonstrating honesty, respect and integrity in all actions is always expected.

Zep Inc. is an organization that is committed to diversity within its workforce and encourages all interested candidates, including women, minorities, and former military personnel to apply. It is the policy of Zep Inc. that all qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, gender, age, disability or sexual orientation.

As an Equal Opportunity and Aff… Employer, Zep Inc. provides full employment opportunities to all qualified persons without regard to race, creed, color, religion, gender, sexual orientation, national origin, age, disability, marital status, ancestry, or veteran status or any other distinction outlined in all applicable federal, state, and local laws.