This position is responsible for assisting Manufacturing Leadership team in ensuring all aspects of manufacturing projects are implemented efficiently, successfully, and within the agreed terms of the project while strictly adhering to current Good Manufacturing Practices (cGMP’s), Environmental Health & Safety (EHS) guidelines, and other regulations that apply. The Manufacturing Project Associate will be key in supporting various projects and activities that focus on continuous improvement, quality, and safety in the manufacturing operations.
Primary Duties and Responsibilities
- Support department goals/objectives including administrative support for data entry and updating manufacturing metric and department scorecard reports.
- Provide support between Manufacturing, Quality Assurance (QA), Quality Control (QC), EHS, Information Technology (IT) and other departments as needed to execute project activities and tasks.
- Support EHS activities as an EHS Coordinator for the manufacturing department.
- Assist manufacturing in Lean implementation which includes 5S, cell layout and improvement, one-piece flow transition, visual management, cycle time reduction, etc.
- Run manufacturing team training gap analysis reports and coordinate SOP and other on the job training for manufacturing employees as needed.
- Support R&D and Validation projects as needed.
- Assist in Non-Conformance (NC), Corrective and Preventative Actions (CPA), Change Control Request (CCR), Observation Report (OR), or other quality system activities.
- Support troubleshooting of process and technical associated problems.
- Initiate and complete document change control to update manufacturing documents which include but is not limited to forms, logs, job-aids, batch records, and Standard Operating Procedures (SOP’s).
- Provide backup support for warehouse and manufacturing related Customer Service requests (CSR) in the uniPoint system.
Job Requirements and Qualifications
· 12 months of work experience in a GMP manufacturing environment.
· Good writing and oral skills
· Proficient at computer usage including MS Office (Word, Excel, PowerPoint, and Visio preferred)
· Ability to quickly learn new software including off-the-shelf software or quality system management software, and in-house developed inventory control software.
· Quick to adapt to technology changes including use of tablets or mobile devices.
· High School Diploma required; bachelor’s degree preferred
Other Knowledge, Skills and Abilities
Consistently takes the initiative to work with others. Changes interpersonal style and approach based on circumstance or audience. Good team spirit, positive attitude. Shows a willingness to work effectively with others.
Accepts and follows directions from leads/management; respects authority; complies with request; does what they are asked to do.
Takes full responsibility for actions and does not make excuses. Understands and exhibits behavior of thinking beyond their role on the team and ensures team’s success beyond their individual contribution. Performs to required standard, owns mistakes and uses them as opportunities for learning and development. Flexes as needed. Accepts constructive feedback and/or consequences without making excuses or blaming others first.
Work Environment (Location, travel, shift, on-call, etc.)
· FLSA Status: Non-Exempt
· This job operates in a professional office, warehouse, and manufacturing environment. Periodic short periods are required in -25°C freezer and gowned in production cleanrooms. Gowning includes the use of coverall type gowns, hoods, boots, gloves, and masks.
· This is a full-time position and work and days are Monday through Friday.
o Primarily in Duarte, CA with infrequent scheduled workdays in City of Industry, CA for any required project support.
Work environment ranges from 25 degrees Celsius to -25 degrees Celsius for short periods of time to retrieve products from the freezer. It is also required to work inside ISO 7/8 clean room which requires gowning includes the use of coverall type gowns, hoods, boots, gloves, and masks.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.