Manufacturing Associate
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
