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About the Role
This entry-level position is a member of the Manufacturing Team, responsible for manufacturing safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role ensures aseptic and sanitary conditions, accurate record-keeping, and professional behavior, while playing a critical role in maintaining production schedules and meeting company goals.
Responsibilities
- Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
- Adheres to good manufacturing practices (GMP & cGMP).
- Performs duties according to the company’s standard operating procedures (SOPs).
- Operates washer and capper machines used in the department.
- Accurately counts work done and keeps necessary records.
- Trays on containers and off loads work in process (WIP) to support filling windows.
- Cleans work areas as needed and documents in appropriate log book.
- Notifies supervisor or lead person of any problems.
- Accurately completes all documentation associated with tasks performed.
- Stocks, gathers, and stages manufacturing supplies and equipment.
- Gathers, stages, and returns production materials as required to support manufacturing activities.
- Cleans and stores manufacturing equipment and areas as required to support manufacturing activities.
- Performs sanitization/disinfection of components, materials, and production supplies to support the manufacturing process.
- Becomes gown qualified, maintains training status, and wears gamma irradiated garments.
- Becomes qualified cleaner for the aseptic processing area.
- Attends all training programs as required by Company SOPs, procedures, and policies.
- Performs any other tasks/duties as assigned by management.
- Keeps work area clean and orderly.
Requirements
- Able to pass gowning qualification and Media Fill Qualification.
- Mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment preferred.
- Ability to take feedback constructively and function in a team-oriented work environment.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
- Ability to work overtime as needed.
- Must become qualified to don Glass Washroom and APA gowning apparel.
- Must become qualified to perform Glass Washroom and APA cleaning.
- Must become qualified to operate washers and cappers.
- Must become qualified to operate aseptic fill room independently.
Skills
- Aseptic filling
- Equipment cleaning and sanitization
- Documentation
- Gowning qualification
- Reading Standard English documents
Location
- Onsite
Work Type
- Full-time
Experience Level
- Entry level
Education Level
- High school diploma or GED preferred
Salary/Compensations
- $26.97 per hour
Benefits
- Healthcare
- Life insurance
- Profit sharing
- Paid time off
- Matching 401k
About the Company
- American Regent celebrates diversity and is committed to creating an inclusive environment for all employees.
- American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users.
Equal Opportunity
- We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
- Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf