QA Compliance Specialist III

At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go.  As employee owners, we support each other in building our careers as well as our companies.  Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!

Summary:  Maintain compliance to procedures for System Investigations, Laboratory Investigations, Corrective and Preventive Actions, Metrics and Annual Product Reviews. Maintain and administer the GMP training program and curriculum, manage the customer complaint system to assure compliance with all cGMP, State and Federal Regulations. 

Primary Responsibilities/Activities: 

• Change order/change control assessments (Stability protocols, IOQ Protocols, Process Validations, Site Master Files, SOPs (MNF, QCU, EM, ERP, CSV), Specification Documents (Packaging components)), Stability Protocols 
• Initiate, review, and close Investigations (SIRs, LIs, CAPAs, and SCARs). Track follow-up items from the investigations. 
• Complete monthly metrics for training, investigations, periodic reviews, change orders/controls. Compile the bi-annual quality metrics reports. 
• Perform Annual Product Reviews to include collecting data, authoring report, and drawing conclusions based upon the data collected on the continued validated state of the product. 
• Review write and/or revise company SOPs as required to assure that procedures remain current. 
• Manage the training program through the electronic document management system. Conduct New-hire training for all new employees. Conduct annual GMP training and other group trainings as needed. 
• Manage customer complaint system, to include logging, investigating and closing complaints, communicating with third party complaint partner, review and approve 1932 reports. 
• Review temperature and humidity reports for each stability chamber for each month and the annual report. Review, sign off, and maintain the records of the QC water testing results 
• Administrator responsibilities for the electronic document management system. 
• Complete quarterly reports (ARCOS) and year-end inventory for controlled substances. 

 Qualifications: 

•  Education: Bachelor’s degree in science related field. 
•  Experience:  Minimum of 3 years’ experience in Quality Assurance or Quality Control. Pharmaceutical experience in a cGMP environment. Experience with electronic document management systems preferred. 
•  Physical Requirements: None 

 

PBI-Gordon Companies and its subsidiaries are proud to offer a comprehensive benefits package to eligible, full-time employees who work 30 hours per week or more. Full-time employees will become eligible to participate in benefits on the first of the month following their start date, unless stated otherwise below. (Note: Interns do not qualify for eligibility.)

Medical Insurance

We are committed to helping you and your dependents maintain health and wellness by offering voluntary, competitive medical insurance and prescription drug plan options.

Dental Insurance

Choose from two voluntary dental plans that are designed to help protect you and your dependents’ oral health. 

Vision Insurance

Our voluntary vision insurance plan is designed to help protect you and your dependents eye health. Coverage is available for eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan.

Life Insurance with Accidental Death & Dismemberment (AD&D)

We offer a company-paid $50,000 life insurance policy with AD&D. You also have the opportunity to purchase additional life and AD&D insurance for yourself, your spouse and/or your dependent children. The cost for this coverage is based on the amount you elect and your age.

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