Senior Manufacturing Associate I (Swing Shift - 1pm - 9:30pm) PC 567
About The Position
This position manufactures biologics under cGMP conditions. The associate follows established procedures, executes batch production records using good documentation practices, and adheres to gowning procedures for work in a cleanroom environment. The role also supports training new hires, troubleshooting, preparing controlled documentation, and other manufacturing duties. The position supports manufacturing schedules by preparing processes, monitoring operations, ensuring equipment is available and released for use, and maintaining supplies. It involves executing and reviewing GMP documentation, assisting with investigations and corrective actions, contributing to the development and review of controlled documents, and maintaining production equipment and inventory. The role collects, trends, and analyzes process data using MS Excel. The role is performed on a swing shift from 1:00 p.m. to 9:30 p.m., Monday through Friday. Work takes place in a temperature-controlled, sanitized laboratory setting. Employees routinely use standard medical and research equipment and are frequently exposed to cultured human cells and lentivirus-derived vector particles. Appropriate protective clothing and equipment are required when entering and leaving the laboratory.
Requirements
- Completion of high school.
- At least 2 years of related experience.
- Ability to communicate production equipment or manufacturing process problems accurately and in detail.
- Ability to provide detailed communication to multiple departments.
- Excellent computer skills.
- Excellent verbal and written communication skills at all levels.
- Quality- and safety-mindedness.
- Ability to learn quickly.
- Ability to handle multiple tasks and work at a rapid pace while maintaining attention to detail.
- Ability to meet the role's physical demands, including walking, standing, using hands, reaching, talking, hearing, climbing or balancing, stooping, kneeling, crouching, and occasionally lifting or moving up to 50 pounds.
Nice To Haves
- Previous GMP experience.
- Previous aseptic technique experience.
Responsibilities
- Follow cleanroom Standard Operating Procedures for gowning, traffic flows, and modes of operation.
- Support manufacturing and production schedules by ensuring equipment is available and released for use, maintaining manufacturing material supplies, and performing process setup, operations, and monitoring.
- Execute batch record instructions and Standard Operating Procedures, complete GMP documentation, and assist in reviewing executed batch records for completeness and accuracy.
- Assist Manufacturing Team Leads with investigations and corrective actions.
- Contribute to the development, writing, and review of Standard Operating Procedures, Material Specifications, Standard Manufacturing Procedures, Batch Production Records, and other GMP documentation.
- Clean, maintain, and use production equipment in accordance with cGMPs, SOPs, and safety policies.
- Maintain inventory and restock supplies as needed.
- Assist in troubleshooting processing issues, supporting investigations, and establishing root cause and resolution or corrective actions.
- Collect, trend, and analyze process data using MS Excel.
- Support training of new hires and perform other manufacturing duties.
Benefits
- Health insurance
- Vision insurance
- Dental insurance
- 401(k) plan
- Certain positions may be eligible for additional compensation such as bonuses or commissions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
