Plant Quality Assurance Specialist

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.

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Job Summary

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.

On-Site Expectations

• 100% on-site position.
• 3rd Shift: Sunday - Friday, 11:00pm - 7:30am.

Responsibilities

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.

Qualifications

• 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.

Knowledge, Skills, and Abilities

• Ability to review batch records, production documentation, and quality records for accuracy, completeness, and compliance.
• Familiarity with deviation management, investigations, CAPAs, root cause analysis, risk assessments, and change control processes preferred.
• Experience supporting material inspection, product release activities, and finished product quality checks.Strong attention to detail with the ability to identify issues, maintain accurate records, and ensure compliance with established procedures.
• Experience creating, reviewing, or updating SOPs, work instructions, forms, training materials, or other controlled documents is preferred.
• Ability to provide real-time quality guidance to production personnel and effectively communicate quality expectations across teams.
• Strong analytical, problem-solving, organizational, and time-management skills.
• Demonstrated ability to support continuous improvement initiatives and drive quality-focused process enhancements.
• Proficiency with Microsoft Office and electronic or paper-based document management systems.
• Excellent verbal and written communication skills, with the ability to collaborate effectively across Quality, Operations, and Production teams.

Physical Demands and Work Environment

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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

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