Manufacturing Associate I-OSD 1st Shift
Alkermes · Wilmington, OH, United States
About The Role
This position reports to a Supervisor, Manufacturing. The hours of this position are Monday to Friday 7:30a to 4:00p. Position Summary: This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches.
Essential Functions: The essential functions of this position include: Production, bulk packaging, and inspection of pharmaceutical drug formulations Assisting with facility cleaning and operational maintenance Cleaning all manufacturing equipment and areas Assisting with facility and process validations as required Assisting with environmental and water system monitoring as required Assisting with RCRA and safety inspections as required Documenting all work as required by cGMPs and GDPs on a timely basis Reading and following all Company SOPs and guidelines Abiding by all safety requirements as defined by the company Completing other tasks as assigned by supervision
Preferred Qualifications: Basic knowledge of the Scientific Method Basic math skills including addition, subtraction, multiplication, division, and percentages Basic knowledge of and adherence to current GMPs and GDPs Basic knowledge of chemistry and biology Basic knowledge of HAZCOM, RCRA, and other Safety requirements Basic level of mechanical aptitude Good documentation skills Ability to learn how to operate all types of production equipment (i.e. Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils, etc.) Ability to read, understand, and accurately follow company SOPs and guidelines Basic knowledge of computer systems (Microsoft Suite, SAP, Veeva Vault, LMS) Understanding and comprehension of Master Batch Records Detail-oriented Willingness to learn new tasks and skills Ability to work well in a team environment Ability to respond quickly and execute assignments Willingness to readily adapt to changing job duties Positive attitude Understanding of and promotion of company and customer objectives Ability to follow all procedures to ensure a high-quality product Education and Experience: Manufacturing Associate I Basic Qualifications: High School diploma or equivalent Preferred Qualifications: 0-1 years of experience in a pharmaceutical manufacturing operation, preferably in OSD A bachelor's degree is preferred; other relevant work experience, education, and training will be considered. Manufacturing Associate II Basic Qualifications High School diploma or equivalent 1-3 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications 1+ year experience in OSD Manufacturing Associate degree or higher in a science/technical discipline Other relative work experience, education, and training will be considered Manufacturing Associate III Basic Qualifications High School diploma or equivalent 4-5 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications 2-3 year experience in OSD Manufacturing Associate degree or higher in a science/technical discipline Other relative work experience, education, and training will be considered Working Conditions: Available for any shift with the possibility for overtime (as necessary) Physical Requirements: Ability to push and/or pull equipment or product using a pallet jack Ability to lift/move 40 lbs. overhead. Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time Must be able to be medically cleared for respirator use (PAPR) Ability to operate different types of production equipment. Ability to gown correctly for clean room manufacturing operations. Ability to stand or sit for extended periods (up to 4 hours at a time). Must be able to work in an office and a manufacturing environment.
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