QA TECHNICIAN 1

Job Details: Job Location: Mooresville - Mooresville, IN, Salary Range: $20.24Hourly, Travel Percentage: None, Job Shift: Day, POSITION PURPOSE

The Product Release Coordinator (PRC) is responsible for coordinating and executing the release of cosmetic, OTC-regulated, and EPA regulated finished products, ensuring compliance with Good Manufacturing Practices (GMP), FDA regulations, and company quality standards. This position reviews batch records including digital data in the Laboratory Information Management System (LIMS) and Shop Floor Control system, collaborates with the Quality Assurance and Manufacturing teams, and prepares Certificates of Analysis (CoAs) and other release documentation as necessary.  This individual also ensures all concerns identified during the data review are properly addressed and documented.  Once the review is complete, the PRC performs the necessary release transactions for each manufacturing lot in the electronic Warehouse Management System(s).  The PRC is responsible for coordinating release activities with the shipping and customer service teams to ensure timely disposition and communication on product availability.  The coordinator is a key link in the safe and compliant release of products, supporting the company’s commitment to consumer safety and regulatory compliance

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Batch Review & Product Release

Review and approve batch records, packaging documentation, and test results for completeness, accuracy and compliance to specifications prior to product release.
Ensure all documentation complies with FDA, cGMP, and internal requirements.

Documentation & Certificate Preparation

Prepare and sign Certificates of Analysis for released product lots, ensuring accuracy and regulatory compliance.
Maintain a repository of release records and related documentation.
Maintain Product Release SOP and other SOP’s as necessary

Cross-Functional Coordination

Collaborate with Manufacturing, Quality Control, and Regulatory Affairs to resolve release-related issues.
Participate in investigations, CAPA (Corrective and Preventive Action), and non-conformance management as needed.

Communication

Communicate release status and critical quality information to internal stakeholders.
Liaise with customers and vendors regarding product status if necessary.

Return Material Authorization (RMA)

Manage verification of returned products for disposition and compliance action.

Audit Support

Support regulatory, customer, and internal audits related to product release documentation and processes.

Training

Responsible for training other team members to perform necessary duties to back-up the PRC role when necessary

Continuous Improvement

Recommend improvements to documentation practices and release procedures for enhanced compliance and efficiency.
Assist in training and implementation of new release procedures.

Qualifications:
QUALIFICATIONS

EDUCATION/CERTIFICATION:

High School Diploma or equivalent

REQUIRED KNOWLEDGE:

Familiarity with cGMP, FDA, and OTC-specific regulatory standards.

Proficiency with documentation, batch record review, and release procedures.

Familiarity with manufacturing processes related to consumer goods.

EXPERIENCE REQUIRED:

Experience in an FDA regulated manufacturing environment (OTC, Pharma, Medical Device, Cosmetic, or Food) is preferred.

SKILLS/ABILITIES:

Strong attention to detail and organizational skills.

Excellent written and verbal communication skills for cross-team coordination.

Ability to interpret quality and regulatory documentation and standards.

Proficiency with Microsoft Office Suite and electronic Quality Management Systems (eQMS) preferred.

Analytical and problem-solving abilities in a fast-paced, regulated environment.

Proficient computer skills to support enterprise resource planning (ERP) (such as Red Prairie, SAP, AS400, Dynamic 365, Oracle) and electronic Quality Management Systems (such as Intelex, MasterControl, Harford, LIMS, Labware, Specright).   

WORKING CONDITIONS

NONE:

No hazardous or significantly unpleasant conditions.