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Manufacturing Associate I-OSD 3rd Shift - 14169

Alkermes, Inc.

Wilmington, OHFull-timeSeen todaySeen in employer's feed today

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At a glance

Compensation
No compensation found
Location
Wilmington, OH
Schedule
Full-time
Work Authorization
Not specified

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Job overview

This entry-level position reports to a Manufacturing Supervisor and works with a small team in a GMP environment to manufacture commercial- and clinical-scale batches. The role includes production, bulk packaging, and inspection of pharmaceutical formulations, along with cleaning, monitoring, validation support, and documentation. The schedule is Monday through Thursday, 9:30 p.m. to 8:00 a.m.

Skills & qualifications

RequiredNice to have

Skills

Scientific MethodBasic MathGMP and GDPChemistryBiologyHAZCOMRCRAMechanical AptitudeDocumentationProduction Equipment OperationMicrosoft SuiteSAPVeeva VaultLMSMaster Batch RecordsAttention to DetailTeamworkAdaptabilityCommunicationProcedure Compliance

Qualifications

High School Diploma or EquivalentBachelor's Degree0-1 Years Pharmaceutical Manufacturing Experience1-3 Years Pharmaceutical Manufacturing Experience4-5 Years Pharmaceutical Manufacturing Experience1+ Year OSD Manufacturing Experience2-3 Years OSD Manufacturing ExperienceAssociate Degree or Higher in Science or Technical DisciplineAbility to Push or Pull EquipmentAbility to Lift 40 Lbs Overhead

Full job description

This position reports to a Supervisor, Manufacturing. The hours of this position are Monday to Thursday, 9:30pm to 8:00am Position Summary: This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Responsibilities 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 Qualifications 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 an

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