Job Title: Manufacturing Associate

Job Description

The Manufacturing Associate is responsible for reviewing documents, records, and procedures that support the release of clinical and commercial GMP products. The role includes participating in the development of GMP operations and reviewing validation documentation, periodic reviews of validated systems, and procedures.

Responsibilities

• Compile and perform lot file reviews, including assessment of manufacturing records, test method data, and deviations for GMP compliance to enable lot release.
• Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations.
• Review certificates of analysis.
• Evaluate discrepancies noted during batch record reviews.
• Conduct GMP incident/deviation reviews.
• Apply the principles of good quality systems and GMP on a daily basis.
• Create and revise standard operating procedures (SOPs) as needed.
• Assist with the reporting and presentation of department metrics, including input into reports for management and annual product quality reviews.
• Assign part and lot numbers and maintain logs.
• Conduct periodic review of validated systems.
• Review validation deliverables for compliance with company policies and procedures.

Essential Skills

• Knowledge of cGMP and applicable FDA regulations.
• Attention to detail and ability to work as part of a team.
• Experience in reviewing GMP documentation, including protocols, reports, batch records, and data.
• Ability to maintain logs and schedules.
• Capability to organize lot documentation, validation plans, protocols, data, and reports in a controlled document system.
• Ability to organize information in a consistent and retrievable manner.
• Ability to work effectively in a fast-paced environment.

Additional Skills & Qualifications

• Laboratory experience.
• GMP knowledge.
• High throughput experience.
• Strong time management and organizational skills.
• Ability to quickly adapt and perform effectively.

Work Environment

The role is based in a fast-paced manufacturing environment where attention to detail and adherence to GMP standards are essential. The candidate will work with laboratory equipment and controlled document systems. Professional attire is expected.