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Production Associate II
at Exact Sciences
- Req No.
- Manufacturing Operations, Facilities & Security
- Regular Full-Time
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
- 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.
- Assist with continuous improvement projects and support other areas needs dependent on demand.
- Perform other related duties as assigned by management.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Strong communication skills and ability to coordinate work with other teams.
- Ability to follow written procedures with minimal direction.
- Demonstrates a basic theoretical understanding of the work tasks assigned.
- 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.
- Regular and reliable attendance.
- Ability to work normal schedule of Monday through Friday during normal business hours.
- 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 lift up to 40 pounds for approximately 25% of a typical working day.
- Ability to work seated for approximately 20% of a typical working day. Ability to work standing for approximately 80% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
- 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 travel between Madison locations.
- Associates degree in life sciences or related field; or high school degree/general education diploma and 2 years of relevant experience in lieu of degree.
- 1+ years of experience working in a relevant manufacturing setting.
- Experience in using basic software applications including Microsoft Office.
- 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.
- Ability to utilize MS-Excel or MS-Word to perform basic calculations, tabulate data and prepare data.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Bachelors degree in life sciences or related field.
- Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.
We are 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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.