QA Specialist

Job Description

Job Description

• Provide support room clearance prior to and during manufacturing
• Review Production campaigns documentation for Products,
• Perform Batch Record review and final disposition of finish product.
• Review data and perform raw material and fill/finish component disposition
• Review clean room logbooks
• Review data to support the testing of site utilities (e.g. WFI, steam, nitrogen, etc.)
• Update, review and/or approval of QMS documentation in document control system (Regulus) e.g. SOP, work instructions, Forms, specifications
• Provide on-the-floor support during manufacturing campaigns for PDS Products, PDS Services and MDS
• Provide on-call support during Manufacturing Operation.
• Issuing product labels
• Perform label reconciliation
• SAP support reviewing inspection plans
• GMP monthly monitoring of the facility (labs, Manufacturing, warehouse)
• Additional task may be assigned based on experience and business need

Deviation Support

• Support Deviation, and Change Controls by completing records, helping with investigations, review or approval of records, and effectiveness checks.

Continuous Improvement

• Participate on product quality and System improvements activities
• Assist on gathering and analyze data to identify opportunities for quality improvement

At Genesis, we love people. Our mission is to be a blessing in all we do while putting people to work. We specialize in partnering with candidates and clients to bring the right people together to accomplish great things.

Genesis Staffing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Genesis Staffing and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at -policy/

Company Description

At Genesis, we love people. Our mission is to be a blessing in all we do while putting people to work. We specialize in partnering with candidates and clients to bring the right people together to accomplish great things.\r\n\r\nGenesis Staffing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.\r\n\r\nBy applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Genesis Staffing and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at