Plant QA Specialist - 4th Shift

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Plant QA Specialist is a hands‑on quality role that serves as the primary quality representative on the production floor, ensuring packaging operations comply with SOPs, GMP requirements, and quality standards. The position is responsible for conducting inspections, reviewing batch records, supporting material release activities, managing deviation documentation, and assisting with investigations, CAPAs, risk assessments, and change controls. This role partners closely with production teams to provide real‑time quality guidance, improve deviation reporting, and support continuous improvement initiatives.

Ideal candidates have a bachelor's degree in a relevant scientific field, experience in quality or manufacturing environments, strong documentation and problem‑solving skills, and familiarity with batch record review, controlled documents, and compliance processes.

• 100% on‑site position.
• 4th Shift: Friday - Sunday, 5:00am - 5:30pm.

Shop Floor Quality & Production Support

• Perform daily quality inspections during packaging operations to ensure compliance with SOPs, work instructions, and quality standards.
• Serve as the first point of contact for production teams on quality‑related questions and issues.
• Provide real‑time guidance and coaching to operators on GMP requirements and proper documentation practices.
• Conduct finished product checks and monitor production activities to ensure products meet release requirements.

Documentation, Batch Records & Material Control

• Review batch records and production documentation for accuracy, completeness, and compliance.
• Support inspection, approval, and release of packaging materials and bulk products.
• Maintain retain sample programs and support Right First Time (RFT) performance reporting.
• Create, review, and update SOPs, work instructions, forms, and training documentation.

Deviations, Investigations & Compliance

• Review and approve minor deviations while ensuring timely and accurate documentation.
• Support investigations of major deviations through data gathering and root cause analysis.
• Assist with CAPAs, risk assessments, change controls, and other quality system activities.
• Guide production staff on deviation reporting processes and compliance expectations.

Training & Continuous Improvement

• Assist in developing and delivering GMP and quality‑related training programs.
• Support implementation of process improvements to enhance quality, compliance, and efficiency.
• Participate in quality projects and help execute operational changes on the production floor.
• Collaborate with cross‑functional teams to identify opportunities for improving procedures and reducing errors.

• Bachelor's degree in Life Sciences, Food Science/Hygiene, Process Engineering, or a related scientific discipline preferred.
• 2-3 years of experience in a Quality Assurance, Quality Control, or quality‑focused support role within pharmaceutical, healthcare, or other regulated manufacturing environments.
• Experience performing shop‑floor quality inspections and supporting production teams in a fast‑paced manufacturing setting.
• At least three years of experience working within a Pharmaceutical cGMP Environment is required for consideration.

• Ability to review batch records, production documentation, and quality records for accuracy, completeness, and compliance.
• Familiarity with deviation management, investigations, CAPAs, root cause…