Specialist QA – Night Shift (5pm-5:30am)

About the role

We are seeking a dedicated Specialist QA to join our Quality Assurance program on a night shift (5:00 pm – 5:30 am). The role involves overseeing product release, validation, and compliance activities for pharmaceutical and related industries while ensuring adherence to the highest ethical standards.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Authorize environmental characterization reports, sanitary utility system releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and lead investigations, site audits, and CAPA records.
• Own site quality program procedures and act as designee for the QA manager on the local CCRB.
• Review risk assessments, work orders, EMS/BMS alarms, and change controls.
• Provide lot disposition decisions and authorize shipments.
• Support automation, facilities, and environmental programs.
• Participate in internal and external audits as a Quality Unit representative.

Required profile

• Doctorate, OR a Master’s degree plus 2 years of related experience, OR a Bachelor’s degree plus 4 years of related experience.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
• Experience with quality disposition of bulk drug substances and pharmaceutical API manufacturing.

Required skills

• cGMP compliance
• cGLP compliance
• Process validation
• Risk assessment
• CAPA management
• Change control
• Lot disposition
• Audit management