Quality Assurance Specialist

The Quality Assurance Specialist provides day-to-day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that production activities comply with cGMP standards, regulatory expectations, and safety requirements while enabling efficient, high-quality output. Key Responsibilities includes : Provide floor-level technical support to manufacturing operators and supervisors. Troubleshoot equipment, process deviations, and workflow bottlenecks. Monitor production performance and assist with implementing corrective actions. Prepare, revise, and maintain GMP documentation including SOPs, batch records, and logbooks. Ensure adherence to FDA and other global regulatory requirements. Support investigations, CAPA development, and change control processes. Perform data collection and review for compliance and continuous improvement. Partner with Process Control to support equipment qualification and validation activities. Assist with process improvements, optimization initiatives, and technology transfers. Support preventive and corrective maintenance coordination with Engineering and Maintenance departments. Train manufacturing personnel on procedures, new equipment, and process changes. Act as a subject matter liaison between Production, Quality and Maintenance teams. Uphold and promote a strong culture of safety and compliance on the production floor. Support environmental monitoring and compliance activities as needed. 1st and 3rd shift positions are available. Typical 1st shift hours are 6:00AM - 4:30PM. Typical 3rd shift hours are 8:00 p.m. to 6:30 a.m. A 15% pay differential applies to 3rd shift work hours. Candidates must be flexible for additional work days per week and/or additional hours per day. Initial orientation and on-the-job training takes place on 1st shift.

Education:

High School Diploma or equivalent. Associates Degree in Sciences, or equivalent, preferred.

Experience:

One to three years in a biotech, pharmaceutical environment or manufacturing environment performing like duties. Candidates must possess mechanical aptitude. Prior experience in a regulated industry is a plus. Training is provided on site. Rate is commensurate with experience.

Job Type:

Full-time Pay:

$25.00 - $30.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Parental leave Referral program Tuition reimbursement Vision insurance

Work Location:

In person