QA Specialist

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