QA Specialist

• Under the direction of the Senior Quality Systems Manager, this position is responsible for maintaining Document Control and Training Management Systems in compliance with internal procedures and applicable global regulations. 
• Ensure products or services meet quality standards and regulatory requirements.
• Review, approve, and release batch records in accordance with approved procedures and documented acceptance criteria within defined timelines.
• Generate certificates of compliance, information sheets, manufacturing declarations and USDSA APHIS documentation for outgoing shipments.
• Perform verification and effectiveness checks for CAPAs, deviations, and nonconformance reports, including documentation of objective evidence to support effectiveness and formal closure.
• Demonstrate working knowledge of cGMP and GDP by independently scheduling and conducting monthly laboratory walk-throughs and annual internal audits based on an approved audit schedule, with documented action reports and follow-up tracking.
• Collaborate cross-functionally to identify documented root causes using appropriate analytical methods and support corrective and preventive actions.
• Complete customer and vendor quality questionnaires.
• Support Management Review meetings by preparing and presenting quality metrics, trends, and performance data to support management review inputs and documented outputs.
• Maintain and manage Quality Management System (QMS) subsystems in accordance with regulatory and standard requirements, including: CAPAs, NCRs, Customer Complaints, Doc Control, Equipment and Facilities support, and Supplier qualification and management. 

• Bachelor’s degree in a scientific discipline or Associate’s degree in a scientific discipline with relevant experience.
• Minimum of 3 years of QA work experience.
• Quality Assurance experience in a cGMP and/or manufacturing environment
• Working knowledge of FDA QMSR, ISO 9001, ISO 13485, ISO 14971
• Experience with GDP

• 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.