Production Associate II
Summary of Major Responsibilities
The Production Associate II will lead or assist in a variety of Production functions which include label printing, bulk reagent production and dispensing, and kitting of finished goods. The position will work within defined protocols and procedures, and may develop and document new procedures for Production. This role is expected to follow procedures with periodic direct supervision.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include but are not limited to the following:
- Participate in or lead simple and complex buffer preparation, Automated Fill / Cap / Label, label printing, and kitting of finished goods. Participate in Capture Bead manufacture.
- Mentor and develop junior level Production associates via operator training/certification programs, acting as a certified trainer.
- Assist in developing, transferring, scaling and validating manufacturing processes, in accordance with company procedures, cGMPs, FDA, and ISO 13485 guidelines.
- Assist or lead process improvement efforts, through the Change Request / Change Order process, or via other means.
- Generate Nonconforming Material Reports, Change Orders, Change Requests, Out of Specifications, Investigations, and Corrective Actions including any deliverables associated with these items.
- Manage inventory via KANBAN system for raw materials, intermediates, disposables and spare parts related to the Production areas.
Occasional Duties and Responsibilities
- Assist with continuous improvement projects and support other areas needs dependent on demand.
- Perform other related duties as assigned by management.
- Strong communication skills and ability to coordinate work with other teams.
- Ability to follow written procedures with minimal direction.
- Strong documentation skills and attention to detail necessary in a GMP environment. Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
- Demonstrates a basic theoretical understanding of the work tasks assigned.
- Ability to utilize MS-Excel or MS-Word to perform basic calculations, tabulate data and prepare data.
- Ability to complete assignments in expected time frames and independently seek out additional work with tasks are completed ahead of time.
- Ability to be involved with trouble shooting and problem solving to learn possible solutions and problems.
- Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.
Education and Experience
- Bachelor’s or Associates’ degree in Life Sciences, or related field or the equivalent combination of education and experience.
- 1-3 years’ experience in a relevant manufacturing setting. Experience in a GMP environment preferred.
- Experience in using basic software applications including Microsoft Office.
- Ability to utilize lab equipment and moving machinery for extended periods of time (includes pipetting, traying robots etc.).
- Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, beard nets, hair nets, booties, hearing protection, etc.) and follow safety guidelines while in the lab etc, for extended periods of time.
- Ability to work at a laboratory bench or fume hood for extended periods of time.
- Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste.
- Ability to use computers daily in an interactive manner for extended periods of time.
- Ability to sit, stand and/or walk for extended periods of time.
- Ability to travel (by land) on occasion.
- Constant walking or motion to coordinate work and interact with employees.
- Ability to perform fine manipulation and simple grasping using hands for extended periods of time.
- Ability to lift and move up to 40 pounds on an occasional basis.
- Regularly sets up, adjusts, assembles, controls, tests, positions and operates objects and equipment weighing up to 20 pounds.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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