Senior Quality Assurance Specialist I (Swing Shift) *PC 1605

Your Role:

This position is primarily responsible to supports QA on-the-floor manufacturing activities, batch record review, and quality system processes to ensure operations are conducted in accordance with current Good Manufacturing Practices (cGMP). The position requires the ability to support swing shift manufacturing operations and occasional weekend work.

Essential Duties and Responsibilities:

• Provide QA on-the-floor oversight during swing shift GMP manufacturing operations, ensuring adherence to approved procedures, batch records, and regulatory requirements.
• Perform review of batch production records, logbooks, and supporting documentation to ensure completeness, accuracy, and compliance prior to QA approval.
• Support real-time manufacturing activities, including line clearance verification, material verification, equipment status checks, and monitoring of critical process steps.
• Author, review, and revise relevant documentation, such as SOPs, Policies and Standards related to GMP compliance requirements.
• Identify and report quality issues, deviations, and compliance risks during manufacturing operations.
• Participate in deviation investigations, assist with root cause analysis, and support implementation of Corrective and Preventive Actions (CAPA).
• Assist with change control documentation and impact assessments related to manufacturing processes and procedures.
• Review and support updates to Standard Operating Procedures (SOPs) and other GMP documentation.
• Collaborate with Manufacturing, Quality Control, and other cross-functional teams to resolve quality issues and maintain compliance.
• Support internal audits and regulatory inspections, ensuring documentation and processes are inspection ready.
• Maintain accurate documentation of QA activities and quality events during shift operations.
• Provide GMP guidance and support to manufacturing staff to ensure proper documentation and process compliance.
• Act as client liaison to monitor client commitments, provide updates at product team meetings and manage progress of commitments to support Operations and Project Management Team.

Requirements:

• Bachelor's degree in Biology, Microbiology, Biotechnology, Chemistry, or related life sciences field. A minimum of 5 years' of Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong experience with QA on-the-floor support and batch record review.
• In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements; Clear understanding of standards of practice used in the manufacture of biotechnology products
• Experience in cell therapy products effectively supporting FDA inspections, EU regulators and client audits.
• Ability to work a swing shift schedule.

Skills:

• Excellent verbal, written, interpersonal, organizational and communication skills.
• Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
• Experience with batch record review and documentation control.
• Experience supporting manufacturing floor operations (QA on the floor).
• Experience with deviation investigations, CAPA, and change control systems.
• Strong communication and cross-functional collaboration skills.
• Ability to support swing shift operations and occasional weekend work.

Physical Demands:

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. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $110,026- $119,719/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.