Job Title: QA Associate

Job Description

The QA Associate is responsible for the rigorous review, verification, and archival of batch records and associated documentation to ensure compliance with internal SOPs, cGMP, and FDA regulations. This role is primarily desk-based and involves close collaboration with production, warehouse, and quality teams to resolve discrepancies and maintain data integrity.

Responsibilities

• Perform comprehensive batch record reviews for completeness, accuracy, and compliance with GDP and SOPs.
• Review supporting documentation including logbooks, protocols, packaging records, and inventory records.
• Collaborate with production and management to resolve discrepancies or missing information in batch records.
• Scan and archive completed records into the electronic database and physical storage system.
• Input data into warehouse management systems (e.g., Dynamics 365) and quality systems (e.g., Reliance).
• Ensure inventory values and documentation are accurately recorded and support initiatives within the QA team to build flexibility and coverage.
• Participate in continuous improvement efforts and assist in training production staff on documentation best practices.
• Cross-trained with other QA Associate functions including Document Control and Inventory Control.
• Issue and control batch records, cleaning records, test sheets, and logbooks.
• Maintain and control the company lot number system and ensure proper documentation flow.

Essential Skills

• Strong interpersonal skills; able to work respectfully with cross-functional teams.
• Self-motivated and organized with a high level of accountability.
• Willingness to learn and adapt to evolving processes and systems.
• Proficient in Microsoft Office and comfortable using ERP and quality systems (e.g., Dynamics 365, Reliance).
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively with minimal supervision.

Additional Skills & Qualifications

• High School Diploma or GED required; Associate’s or Bachelor’s degree in a scientific or technical field preferred.
• 1+ year of experience in pharmaceutical QA or FDA-regulated environment preferred.
• Strong attention to detail and ability to work in a fast-paced, documentation-heavy environment.

Work Environment

This position is a Monday to Friday Day Shift role with a flexible start time between 7:00 - 8:30 AM, working 8-9 hours from there. The role includes 90% desk-based work in a shared office setting, with occasional lifting of up to 50 lbs. The manufacturing building is dusty due to the powdered products produced and is not a sterile environment. The team comprises 3 Inspectors, 1 Supervisor, 3 Batch Record Reviewers, 1 Document Control, and 1 Inventory Control.