Manufacturing Specialist

Position Overview

The Manufacturing Specialist supports day-to-day sterile manufacturing operations by providing coordination, documentation, and technical support to the Manufacturing team. This role plays a key part in ensuring efficient execution of production schedules, accurate documentation, and timely resolution of manufacturing events.

The Manufacturing Specialist works closely with Production, Quality Assurance, Quality Control, and Engineering to support scheduling activities, deviation investigations, and other operational support functions in a cGMP-regulated sterile injectable manufacturing environment.

Key Responsibilities

Manufacturing Operations Support

• Support manufacturing leadership with production scheduling coordination, including preparation, tracking, and communication of manufacturing timelines.

• Assist in coordinating resources, materials, and documentation to support scheduled manufacturing activities.

• Act as a liaison between Manufacturing, QA, QC, and Engineering to ensure alignment on production readiness and priorities.

Deviation and Investigation Support

• Support deviation initiation, investigation, and documentation, including data gathering, timeline development, and draft investigation writing.

• Assist manufacturing personnel in documenting events accurately and in compliance with cGMP and data integrity requirements.

• Track deviation and CAPA status to ensure timely completion and closure.

• Support root cause analysis activities and implementation of corrective and preventive actions.

Documentation and Compliance

• Assist with preparation, review, and reconciliation of manufacturing documentation, including batch records and logbooks.

• Ensure manufacturing records are accurate, complete, and contemporaneous in accordance with ALCOA+ principles.

• Support change control documentation related to manufacturing processes, equipment, or procedures.

• Participate in continuous improvement initiatives to improve documentation quality and right-first-time performance.

Cross-Functional Support

• Support internal and external audits by assisting with document retrieval and response preparation related to manufacturing activities.

• Participate in production meetings, providing updates on scheduling, documentation, and investigation status.

• Assist with training coordination and tracking for manufacturing personnel as needed.

What We Are Looking For

• Strong Organizational Skills: Ability to manage multiple priorities and support manufacturing operations in a fast-paced environment.

• Quality and Compliance Mindset: Understanding of cGMP principles and the importance of accurate, compliant documentation.

• Clear Communication: Able to communicate effectively across Manufacturing, Quality, and Engineering teams.

• Problem-Solving Ability: Capable of gathering information, analyzing issues, and supporting effective root cause investigations.

• Attention to Detail: Strong focus on accuracy and completeness in documentation and reporting.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology, or a related field preferred.

• 3-5 years of experience in pharmaceutical manufacturing, sterile operations, or a cGMP-regulated environment preferred.

• Familiarity with sterile injectable manufacturing or aseptic processing is a plus.

• Experience supporting deviation investigations, documentation, or manufacturing operations is

Preferred.

• Working knowledge of FDA cGMP regulations (21 CFR Parts 210 and 211).

• Strong written and verbal communication skills.

• Proficiency in Microsoft Office and familiarity with electronic quality management systems (eQMS) is a plus.

Preferred Skills

• Experience supporting manufacturing scheduling or production planning activities.

• Familiarity with root cause analysis tools (e.g., 5 Whys, Fishbone).

• Exposure to continuous improvement initiatives in a manufacturing environment.

• Ability to work effectively in cross-functional teams.

Please submit resume to ***email_hidden***