Manufacturing Associate

Manufacturing Associate

The Manufacturing Associate is responsible for supporting daily pharmaceutical manufacturing operations, ensuring all production activities are performed in compliance with current Good Manufacturing Practices (cGMP), safety requirements, and internal quality standards. This role assists with formulation, aseptic processing, filling, inspection, packaging, equipment operation, documentation, and cleaning activities within a regulated sterile manufacturing environment.

The ideal candidate is detail-oriented, quality-focused, and committed to maintaining compliance, safety, and operational excellence while supporting the production of sterile injectable pharmaceutical products.

Key Responsibilities

Manufacturing Operations

• Operate pharmaceutical manufacturing equipment including mixing, filling, sterilization, inspection, labeling, and packaging equipment in accordance with SOPs.
• Support formulation, aseptic filling, inspection, and production of sterile injectable products.
• Execute manufacturing activities in compliance with approved batch records and production schedules.
• Perform line clearances, equipment setup, and product changeover activities.
• Monitor manufacturing processes and report any abnormalities or production issues.

Documentation & Compliance

• Accurately complete batch records, logbooks, equipment logs, and production documentation.
• Ensure all manufacturing activities comply with cGMP, GDP, SOPs, and regulatory requirements.
• Maintain data integrity and documentation accuracy throughout the manufacturing process.
• Report deviations, non-conformances, and quality concerns promptly to supervision.

Equipment Cleaning & Maintenance

• Perform cleaning, sanitization, and preparation of manufacturing equipment and production areas.
• Support preventative maintenance activities and equipment readiness initiatives.
• Verify equipment status and cleanliness prior to production activities.
• Assist with maintaining manufacturing tools and equipment in proper working condition.

Environmental, Health & Safety Compliance

• Maintain a safe, clean, and organized work environment.
• Comply with company safety policies, OSHA requirements, and cleanroom procedures.
• Wear required personal protective equipment (PPE) and follow gowning procedures.
• Promote a culture of safety, quality, and continuous improvement.

Cross-Functional Collaboration

• Work closely with Production, Quality Assurance, Quality Control, Engineering, and Maintenance teams.
• Support investigations, corrective actions, and process improvement initiatives.
• Assist in manufacturing process optimization and operational efficiency projects.
• Communicate effectively with supervisors and team members regarding production status and issues.

Qualifications

Required

• High School Diploma or equivalent.
• 0-2 years of experience in pharmaceutical, biotechnology, medical device, or manufacturing environments.
• Basic understanding of cGMP requirements and manufacturing documentation practices.
• Strong attention to detail and commitment to quality.
• Ability to follow written procedures and verbal instructions accurately.
• Ability to work effectively in a team-oriented environment.
• Willingness to work shifts, weekends, overtime, or extended hours as needed.

Preferred

• Diploma or Bachelor's Degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related field.
• Experience in sterile manufacturing or injectable pharmaceutical production.
• Knowledge of aseptic processing and cleanroom operations.
• Experience working within a regulated pharmaceutical manufacturing environment.

Key Competencies

• Pharmaceutical Manufacturing Operations
• cGMP & Regulatory Compliance
• Sterile Manufacturing Practices
• Documentation & Data Integrity
• Attention to Detail
• Equipment Operation & Cleaning
• Safety & OSHA Compliance
• Problem Solving
• Teamwork & Collaboration
• Communication Skills
• Continuous Improvement
• Time Management
• Adaptability & Flexibility
• Quality Focus

What Success Looks Like

• Consistently performs manufacturing activities safely, accurately, and in compliance with cGMP requirements.
• Maintains complete and accurate production documentation with minimal errors.
• Supports production schedules and contributes to achieving manufacturing targets.
• Demonstrates strong adherence to quality, safety, and sterile manufacturing standards.
• Effectively identifies and escalates production, quality, or safety concerns.
• Contributes to a clean, organized, and audit-ready manufacturing environment.
• Works collaboratively with cross-functional teams to support operational excellence and continuous improvement initiatives.
• Helps ensure the reliable production of high-quality sterile pharmaceutical products.