Quality Assurance Specialist

Quality Assurance Specialist - 3rd shift

Job Description

The Quality Assurance Specialist supports production operations by spending the majority of their time on the manufacturing floor, performing verifications, walkthroughs, onsite reviews, and mini audits to ensure processes follow established procedures and regulatory requirements. This role also reviews and issues critical documentation, such as executed batch records, cleaning records, and logbooks, and helps identify and implement solutions when issues arise, including initiating deviations and supporting CAPA activities.

The position combines hands-on floor presence with office-based documentation review and reporting.

Responsibilities

* Spend approximately 60-70% of working time on the production floor supporting operations and verifying that activities comply with established procedures and quality standards.

* Conduct routine walkthroughs of production areas to observe operations, identify potential issues, and ensure processes occur as intended.

* Perform onsite reviews and mini audits to confirm adherence to GMP, FDA, ISO, and internal quality requirements.

* Collaborate with operations personnel to identify problems, propose solutions, and help initiate deviations when necessary.

* Review executed batch records, cleaning records, logbooks, and other quality-related documents for accuracy, completeness, and compliance.

* Issue batch records as needed to support production activities and ensure proper documentation is in place before manufacturing.

* Document findings from floor walkthroughs, reviews, and audits, and report observations to appropriate stakeholders in a clear and timely manner.

* Support CAPA and document control activities related to quality events, deviations, and audit findings, as needed.

* Follow area-specific gowning and safety requirements, ranging from safety shoes to full gowning, depending on the production area.

* Use electronic quality management systems (EQMS) and other office tools to manage documentation, track activities, and maintain records.

Essential Skills

* 0-2+ years of experience in a regulated industry environment such as GMP, FDA, or ISO-regulated operations.

* Understanding of quality assurance principles within a pharmaceutical or similarly regulated manufacturing setting.

* Experience or familiarity with batch records, batch record review, and document control practices.

* Knowledge of CAPA processes and deviation management in a regulated environment.

* Ability to perform audits, mini audits, and onsite reviews with attention to detail and compliance.

* Comfort working on a production floor and interacting closely with operations teams.

* Ability to follow and enforce GMP, FDA, and ISO requirements and internal procedures.

* Strong documentation, organizational, and reporting skills.

* Ability to work 12-hour shifts on a rotating schedule, including overnight hours for third shift.

Additional

Skills & Qualifications

* Bachelor's degree in any science discipline preferred.

* Experience in pharmaceutical manufacturing or a similar regulated production environment preferred.

* Familiarity with FDA regulations and pharmaceutical quality systems preferred.

Work Environment

This is an on-site role based primarily on the production floor, with the majority of time spent in manufacturing areas and the remainder in an office setting for documentation and reporting. Current openings are on third shift. New hires begin on first shift (Monday-Friday, 8:00 a.m. to 4:30 p.m.) for approximately 6-8 weeks of training, with efforts made to have team members on the same shift train together.

The environment includes time on the production floor and time in an office area outside of production, with regular interaction with an electronic quality management system (EQMS) and other office tools. Gowning and attire requirements vary by area, ranging from safety shoes to full gowning, depending on the specific production zone and safety protocols. The team structure consists of a small group of quality professionals working closely with operations in a fast-paced, highly regulated manufacturing setting.

Job Type & Location

This is a…