Topicals Operator I - 2nd Shift
Amneal
Summary
The Manufacturing Operator performs the set-up, operation, and cleaning of pharmaceutical processing equipment used in the manufacture of topical products, including creams, ointments, and lotions. The role is responsible for executing batch records, maintaining accurate GMP documentation, and following all applicable SOPs, cGMP requirements, and safety procedures to support safe, compliant, and efficient production.
Job description
Essential Functions
- Execute the production schedule as planned, ensuring equipment/material availability prior to executing the day's production. Perform all required tasks with minimal supervision.
- Responsible for 100% documentation accuracy on all GMP documents, such as batch records, log books, training records, in-process forms.
- Responsible for overall appearance of the processing suites, ensuring all suites, hallways, washroom, and storage areas are clean and well kempt as per GMP guidelines and SOP procedures.
- Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
- Responsible for reporting to the department supervisor any issue/concern, or potential issue/concern that may negatively impact the outcome of the successful execution of a batch.
- The Operator will immediately notify the department supervisor if he/she observes any action or activity that is a violation of cGMPs, Procedures, or Safety, or any outside factor that may impact the safety, strength, efficacy of the product.
- Work closely with Technical Writer in generating detailed equipment SOP's, focusing on set-up, operation, and cleaning.
Additional Responsibilities
- Secondary role, when not needed in Manufacturing, is to support other department activities, such as Packaging, and Pharmacy.
- Participate in the generation of "Task Qualification Checklists" for the Certified Trainer Program, and train new operators as required.
Qualifications
- High School or GED - Required
- 1 year or more in pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment
- Previous pharmaceutical operations experience GMP & SOP familiarity
- Previous experience operating pharmaceutical processing equipment, particularly packaging equipment
- Lean Six Sigma training/experience a major plus
- Excellent written skills
- Must have good verbal communication skills in English
- Must possess analytical problem solving and troubleshooting skills
- Must have the ability to interact with individuals from all levels throughout the organization
- Must be a motivated self starter, requiring little to no supervision to accomplish their daily tasks
- Must have the ability to generate reports/response to investigations
- Must have excellent attention to detail
- Must be an excellent "team" player – assisting co-workers when necessary, and providing training and guidance as needed, particularly to new operators.
Requirements
- High School or GED
- 1 year or more in pharmaceutical manufacturing environment
- Experience operating cream/ointment/lotion processing equipment
- GMP & SOP familiarity
- Excellent written skills
- Good verbal communication skills in English
- Analytical problem solving and troubleshooting skills
- Ability to interact with individuals from all levels
- Motivated self starter, requiring little to no supervision
- Ability to generate reports/response to investigations
- Excellent attention to detail
- Excellent team player
Benefits
- Short-Term Incentive Opportunity
- Long-Term Incentive Award
- Health Insurance
- Insurance Benefits
- 401(k) Matching Contribution
- Employee Well-Being Programs
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.