Associate Manufacturing Specialist

Alcami Corporation • Morrisville, NC

7d • Onsite

About The Position

The Associate Manufacturing Specialist drives results in a fast-paced environment by manufacturing products according to specific protocols and in full compliance with cGMP procedures and guidelines. The role handles, reviews, and ensures the accuracy, completeness, and compliance of manufacturing documentation associated with formulation and aseptic filling operations. It upholds Good Documentation Practices (GDP) and processes batch records efficiently to support on-time product release.

This is a 100% on-site position on the first shift, Monday through Friday, from 8:00 a.m. to 4:30 p.m. The role may require periodic presence on the production floor, up to 5% travel, and extended hours during peak production or release periods.

The employee regularly uses hands and arms for handling and reaching, and regularly talks, hears, and smells. Standing is frequent; walking, sitting, and stooping, kneeling, crouching, or crawling are occasional. Lifting or moving up to 10 pounds is regular, up to 25 pounds is frequent, and up to 50 pounds is occasional. The job involves frequent exposure to moving mechanical parts and risks of electrical shock, burns, and microbial contamination, and occasional exposure to fumes or airborne particles, toxic or caustic chemicals, and vibration. Noise is usually moderate. Appropriate personal protective equipment is required for specific duties and may include safety eyewear, respirators or breathing apparatus, lab coats, full protective body coverings, and gloves.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field preferred; equivalent experience considered.
• 1–3+ years in a related GDP environment.
• Strong attention to detail and ability to identify errors and inconsistencies.
• Strong verbal and written communication and documentation skills.
• Strong detail orientation and organizational skills.
• Ability to collaborate cross-functionally and provide constructive feedback.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work extended hours during peak production or release periods.
• Ability to use Microsoft Office, including Word, Excel, and PowerPoint.
• Ability to meet the described physical demands and wear appropriate personal protective equipment for assigned duties.

Nice To Haves

• Pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred.
• Experience with batch record review, GDP, or cGMP environments is highly desirable.

Responsibilities

• Receive, organize, and manage formulation and aseptic filling batch records and associated documentation.
• Perform detailed batch record reviews for accuracy, completeness, and compliance with cGMP, GDP, and internal SOPs.
• Identify and document discrepancies, errors, and missing information or reports, and facilitate their resolution.
• Complete record reviews in time to meet established batch release timelines.
• Provide feedback and training to manufacturing technicians to support right-first-time manufacturing initiatives.
• Review logbooks and support corrective action as necessary.
• Serve as a subject matter resource for GDP requirements across manufacturing teams.
• Ensure documentation is legible, traceable, contemporaneous, accurate, and compliant with regulatory expectations.
• Control revision processes and ensure the correct versions of forms and records are in circulation.
• Support internal and external audit readiness by ensuring documentation is accurate and available.
• Train manufacturing personnel on documentation practices, batch record and logbook review, and batch record handling expectations.
• Coach operators and supervisors to strengthen the compliance culture.
• Participate in root cause analysis for documentation-related deviations or recurring errors.
• Recommend and support implementation of documentation process improvements.
• Work with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs and timelines.
• Support investigations by providing documentation insights and historical reference.
• Assist in preparing documentation summaries or metrics for management review.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level