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Temp-Compliance Specialist-Manufacturing - 13597

Alkermes, Inc.
Wilmington, OH
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291031223 Summary The Manufacturing Compliance Specialist establishes, ...
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monitors, and maintains GMP systems for the OSD manufacturing processes. Essential Functions Review completed GMP documentation to ensure it is complete and accurate in preparation for product release. Work with the Solid Oral Dose team to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production). Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing...
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Dir, Quality Assurance - 13521

Alkermes, Inc.
Wilmington, OH
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291031292 POSITION SUMMARY Provide a brief description of the general nature ...
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of the position; an overview of the purpose and objective of this position and reporting relationships. (Why does this job exist) Management of Quality Assurance functions across the Wilmington, Ohio site. Ensure that the site operates in compliance with FDA, EU and all other regulations as required, and remains inspection ready at all times. Interface with FDA, other regulatory agencies, customers and consultants. Liaise with corporate functions across the company. MAJOR RESPONSIBILITIES Major Responsibility...
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Applied Math
5
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5
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5
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Manufacturing Associate I-Filling 1st Shift - 13593

Alkermes, Inc.
Wilmington, OH
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291031173 This position is based in Wilmington, OH Summary: Perform all ...
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necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job...
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Certifications / Licenses:
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
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Manufacturing Associate I-Filling 3rd Shift - 13584

Alkermes, Inc.
Wilmington, OH
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290900686 This position is based in Wilmington, OH The schedule for this ...
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position is Monday through Thursday nights from 10:00pm to 8:30am. Summary: Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed....
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From:
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Certifications / Licenses:
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
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Territory Business Manager Psychiatry – Dayton - 13590

Alkermes, Inc.
Dayton, OH
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290900546 Territory Business Manager (TBM) is responsible for selling ...
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Alkermes products in the Southwest Ohio territory and supporting promotional efforts. Ideal candidates should be proven sales achievers and live in the territory. This will be done by having thorough product, disease state and market knowledge and sound selling skills. He/she will utilize available resources to help educate healthcare providers. Finally, he/she will use their analytical ability to determine appropriate targets and will use approved resources accordingly. Responsibilities The TBM will demonstrate a strong...
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Workkeys
Applied Math
5
Graphic Literacy
5
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5
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QC Analyst II - 3rd Shift - 13579

Alkermes, Inc.
Wilmington, OH
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290606456 Overview: The 3rd Shift QC Analyst II must have broad knowledge of ...
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all the techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment. Responsibilities: Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility,...
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Applied Math
6
Graphic Literacy
6
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5
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Process Engineer I/II/Lead-OSD - 13583

Alkermes, Inc.
Wilmington, OH
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290606323 Summary This position will support and assist in manufacturing ...
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pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure...
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Workkeys
Applied Math
5
Graphic Literacy
6
Workplace Documents
7
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QA Associate III/Sr. QA Associate I - 13581

Alkermes, Inc.
Wilmington, OH
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290452531 Overview: Job Description: This function is responsible for ...
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supporting the daily manufacturing and facility operations along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise Deviations, and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of...
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From:
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Certifications / Licenses:
Workkeys
Applied Math
4
Graphic Literacy
5
Workplace Documents
5
apply
Detailed Job Information

Manufacturing Associate I-Filling 1st Shift - 13585

Alkermes, Inc.
Wilmington, OH
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290452688 This position is based in Wilmington, OH Summary: Perform all ...
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Summary
About the job:
necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job...
Location:
Job Type:
Occupation:
Career Level / Education:
Salary:
From:
OhioMeansJobs.com
Certifications / Licenses:
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

District Business Leader – Lower Michigan - 13578

Alkermes, Inc.
Toledo, OH
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290263568 Reporting to the Senior Regional Director, the District Business ...
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Leader (DBL) will be responsible for achieving business objectives by leading a team of Territory Business Managers (TBMs) in the successful promotion of ARISTADA, LYBALVI, and future neuroscience pipeline products & services. This will be accomplished by successfully leading, coaching and developing a diverse, high-performing sales team to exceed sales goals within an assigned geographic area. Key attributes necessary for success will be the ability to inspire and motivate a high performing, results oriented team,...
Location:
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Occupation:
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From:
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Certifications / Licenses:
Workkeys
Applied Math
5
Graphic Literacy
5
Workplace Documents
5
apply
Detailed Job Information
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