QA Specialist - On the Floor Support (3rd Shift)

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! We are seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. The role ensures cGMP compliance, supports production activities, and promotes a strong quality culture. The ideal candidate is detail-oriented, hands-on, and able to provide guidance to operators while maintaining inspection readiness. ### Responsibilities - Maintain a daily presence on the production floor to provide real-time QA support and guidance. - Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection activities. - Perform QA line clearances, in-process checks, and AQL inspections, and support visual inspection and automated inspection processes. - Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements. - Routinely walk through production, lab, and warehouse areas to assess GMP compliance and escalate issues as needed. - Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products. - Provide on-the-floor coaching and guidance to operators, reinforcing GMP compliance and best practices. - Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow. - Monitor cleaning, sanitization, and environmental controls prior to critical operations. - Promote a quality-focused culture by sharing lessons learned and encouraging proactive issue identification. - Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required. - Assist in gathering facts, reviewing documentation, and providing QA input when deviations occur on the floor. - Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions. - Review, revise, and proofread GMP documentation, including batch records, SOPs, and logbooks. - Support document control processes and ensure training documentation is correctly linked to controlled systems. - Ensure compliance with regulatory standards (FDA, ICH, DEA) and Good Documentation Practices. - Conduct routine walk-throughs to maintain inspection readiness. - Support internal audits and regulatory inspections by providing floor-level guidance and documentation as needed. ### Qualifications - Bachelor’s degree in a scientific discipline or equivalent experience. - 2–5 years in a GMP-regulated environment, with experience in on-the-floor QA support. - Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices. - Familiarity with Master Control or electronic quality systems preferred. - Strong communication, problem-solving, and interpersonal skills. - Regular presence in GMP manufacturing and cleanroom environments with proper gowning. - Occasional off-shift, weekend, or extended coverage may be necessary. Preferred Qualifications: - Experience with automated visual inspection processes. - Knowledge of controlled substance handling. - Prior involvement in regulatory inspections. ### Work Environment & Physical Demands **ADA Accommodation Notice** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Physical Requirements** - Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks. - Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE). - Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities. - Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures ### Shifts 2nd shift: 3:00pm - 11:30pm , Monday - Friday 3rd shift: 11:00pm - 7:30am , Sunday - Thursday Weekend Day shift: 7:00 am - 7:00 pm, Friday - Sunday