POSITION TITLE
Quality Compliance Specialist
POSITION SUMMARY
The Quality Compliance Specialist supports the execution and maintenance of site Quality Systems to ensure full compliance with applicable regulatory requirements (FDA, EMA, ICH), current Good Manufacturing Practices (cGMP), internal Standard Operating Procedures (SOPs), and company quality standards within a pharmaceutical manufacturing environment.
This role is responsible for assisting in the administration of quality systems, supporting inspection readiness, and driving compliance activities across the site. The Quality Compliance Specialist partners cross-functionally to ensure consistent application of quality processes and contributes to continuous improvement initiatives. This position reports directly to the Quality Assurance Systems and Compliance Manager.
PRIMARY DUTIES & RESPONSIBILITIES
Quality Systems & Compliance Support
Support the administration and maintenance of core Quality Systems, including:
Change Control
Learning Management System (LMS)
Document Control and Records Management
Retention/Retains programs
Ensure quality system activities are executed in compliance with regulatory requirements, cGMP, and internal procedures.
Assist in tracking, trending, and reporting quality metrics (KPIs) to support site compliance and performance monitoring.
Documentation & Document Control
Author, revise, and review SOPs, work instructions, and other controlled documents.
Ensure accurate, timely, and compliant document management within electronic or manual systems.
Support records management activities, including archiving and retrieval.
Audit & Inspection Readiness
Support internal, regulatory, and customer audits and inspections
Track and support closure of Corrective and Preventive Actions (CAPAs) to ensure timely completion.
Training & LMS Administration
Support administration of the Learning Management System (LMS), ensuring training assignments and completions are compliant.
Monitor training compliance and follow up on overdue training.
Assist with training record maintenance and reporting.
Supplier & Product Quality Support
Support Supplier Quality activities, including associated onboarding activities/evaluations, maintenance of the approved supplier lists, and coordinating the associated site supplier audits per schedule.
Assist with Annual Product Review (APRs) data collection and compilation.
Support complaint handling/SCAR activities, including documentation and tracking to timely closure.
Validation & Data Integrity Support
Provide support for validation documentation (CSV, process validation, cleaning validation) as required.
Ensure adherence to data integrity principles (ALCOA+) across systems and documentation.
Other Responsibilities
Partner with Manufacturing, Quality Control, Maintenance, Regulatory Affairs, and Supply Chain to ensure alignment with quality and compliance requirements.
Maintain knowledge of current regulatory expectations and industry best practices.
Perform additional duties as assigned, consistent with the scope of the role.
WORK ENVIRONMENT & SAFETY
PTI is a manufacturing plant work environment that produces FDA regulated products, including topical and ingestible powders for the pharmaceutical, nutritional, and cosmetic industries. Typical exposures regardless of individual job positions include active pharmaceutical ingredients (API), powders, dust, odors (including menthol) and cleaning solvents. Standard work hazards include proximity to moving equipment, conveyor belts, heavy object transport, working at heights (step ladders, lifts, etc.), noise >85 decibels, repetitive motions, powered doorways, dock operations and driving/walking hazards. We are committed to safety and will take every precaution to ensure a safe working environment for our employees.
DISCLAIMER & EQUAL OPPORTUNITY
The above information on this description has been designed to indicate the general functions and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of any employee assigned to this job. Reasonable accommodation will be made for employees with disabilities to perform job functions. PTI is an Equal Opportunity Employer.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Application Question(s):
- Will you now or in the future require sponsorship for employment visa status?
Ability to Commute:
- Royston, GA 30662 (Required)
Work Location: In person
