Manufacturing Associate
About The Position
As a manufacturing associate with a moderate to high level of technical expertise and experience, you will independently perform routine operations and may handle more complex tasks within your scope of training. You will actively participate in the day-to-day operations of a cGMP-compliant manufacturing facility and may assist in troubleshooting and minor problem-solving. You will execute work instructions and apply job skills to complete assignments, achieve full training status, and assist training staff. You will work on semi-routine assignments, receiving instruction on new processes. You will maintain inventory records and accurate batch records, inspect finished products for adherence to specifications, and assist with batch record reconciliation and preventative maintenance tasks. You will adhere to Quality Management Systems and assist with Nonconformance/CAPA closures. You will identify and communicate items requiring escalation and maintain a clean and safe work environment. You will follow company policies including safety, training, GDP, and cleanroom gowning. You will spend 90% of the time in manufacturing suites.
Requirements
- Minimum of 1 year of work experience in manufacturing, operations, production, lab setting or related field.
- High school diploma or equivalent required.
- Ability to function in a dynamic environment and balance multiple priorities.
- Proficiency in learning new software and tools.
- Ability to make decisions for moderately complex GMP manufacturing activities with minimal to moderate supervision.
- Ability to recognize, understand, and respond to situations requiring further evaluation and report to senior operators or management.
Nice To Haves
- Experience in a cGMP environment.
- Technical expertise in biopharmaceutical manufacturing equipment, principles, and processes.
- Strong understanding of current GMP and safety standards.
Responsibilities
- Independently perform routine operations and handle more complex tasks within scope of training.
- Actively participate in day-to-day operations of a cGMP-compliant manufacturing facility.
- Assist in troubleshooting and minor problem-solving.
- Execute work instructions and apply job skills to complete assignments.
- Achieve full training status and assist training staff.
- Work on semi-routine assignments, receiving instruction on new processes.
- Maintain inventory records and accurate batch records.
- Inspect finished products for adherence to specifications.
- Assist with batch record reconciliation and preventative maintenance tasks.
- Adhere to Quality Management Systems and assist with Nonconformance/CAPA closures.
- Identify and communicate items requiring escalation.
- Maintain a clean and safe work environment.
- Follow company policies including safety, training, GDP, and cleanroom gowning.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
