Associate Manufacturing 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.

Are you interested in joining our team?

The Associate Manufacturing Specialist is accountable for driving results in a fast-paced environment by being responsible to manufacture various products following a specific protocol while in full compliance with all cGMP procedures and guidelines.

The Associate Manufacturing Specialist is responsible for handling, reviewing, and ensuring the accuracy, completeness, and compliance of all manufacturing documentation associated with formulation and aseptic filling operations. This role ensures that Good Documentation Practices (GDP) are consistently upheld and that batch records are processed efficiently to support on-time product release.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 4:30pm.

Batch Record Handling & Review:

• Receive, organize, and manage all formulation and aseptic filling batch records and associated documentation.
• Perm detailed review of batch records for accuracy, completeness, and compliance with cGMP, GDP, and internal SOPs.
• Identify, document, and facilitate resolution of discrepancies, errors, and missing information / reports.
• Ensure timely completion of record review to meet established batch release timelines.
• Provide feedback and training to manufacturing technicians to support right first-time manufacturing initiatives.
• Perform logbook reviews and support corrective action as necessary.

Documentation Quality & Compliance

• Serve as subject matter resource for GDP requirements across manufacturing teams.
• Ensure documentation is legible, traceable, contemporaneous, accurate, and compliant with regulatory expectations.
• Maintain control of revision processes and ensure the correct versions of forms and records are in circulation.
• Support internal and external audit readiness by ensuring documentation accuracy and availability.

Training & Continuous Improvement

• Train manufacturing personnel on proper documentation practices, batch record / logbook review, and general batch record handling expectations.
• Provide feedback and coaching to operators and supervisors, to strengthen compliance culture.
• Participate in root cause analysis for documentation-related deviations or recurring errors.
• Recommend and support implementation of documentation process improvements.

Cross-Functional Support

• Work closely with Manufacturing, Quality Assurance, and Supply Chain to align on documentation needs and timelines.
• Support investigations by providing relevant documentation insights and historical reference.
• Assist in preparing documentation summaries or metrics for management review.
• May require periodic presence on the production floor.
• Other duties as assigned.

• Bachelor’s degree in Life Sciences, Engineering, or a related field preferred; equivalent experience considered.
• Must have 1 - 3+ years in related GDP environment. Pharmaceutical, biotech, or aseptic manufacturing operations work experience preferred.

• Experience with batch record review, GDP, or cGMP environments highly desirable.
• Strong attention to detail and ability to identify errors and inconsistencies.
• Strong verbal and written communication and documentation skills required.
• Strong detail orientation and organizational skills required.
• 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.
• Able to work…