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END DATE March 06, 2012

Quality Assurance Supervisor

Amylin Pharmaceuticals Inc. - Cincinnati, OH


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Job Description

Responsible for supervising personnel that are responsible for real-time MBR review, on-the-floor QA oversight, AQL inspections, and line clearances.
Responsibilities: The ideal candidate will be responsible for individuals that work across multi-shifts and will support 24/7 manufacturing operations. Responsible for real-time support of manufacturing operations. Responsible for managing issues, alarms, etc. Oversight to ensure that MBRs and critical documentation is being reviewed and approved real-time. Interpret quality standards to ensure that all manufacturing operations comply with current industry and regulatory requirements. Ensure AQL activities are performed for inspection and packaging operations. Oversight of Line Clearances and Quality Assurance samples.Support in the batch disposition process.Perform other duties as assigned, and in accordance with Company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, rules and regulations. Responsible for supervisor functions such as:
Personnel Reviews, Personnel Development Plans, Daily Schedules, and Personnel Training. Qualifications:- BS in a scientific discipline with at least 2 years of related supervision experience; pharmaceutical or biotech experience required.
- A minimum of 3 years direct experience in Quality Assurance is required with previous manufacturing experience. - Knowledge of FDA and EU regulations and a strong working knowledge of GMP regulations.- Experience in pharmaceutical operations is required.- Candidate must display strong interpersonal skills, along with strong organizational abilities.- Solid technical writing and documentation skills are required; the ability to communicate effectively and interact with multi-disciplinary teams is required. - Strong leadership skills are required. Requirements:Physical Demands Must be able to lift at least 25 lbs. Hours of operation will be at the discretion of the candidate, but will need to ensure proper support to all shifts. Manual Dexterity Frequently use a computer keyboard, PDA or other electronic devices. Audible/Visual Demands Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents. Environment Laboratory, Office and Manufacturing environments. Requirements:Physical Demands Must be able to lift at least 25 lbs. Hours of operation will be at the discretion of the candidate, but will need to ensure proper support to all shifts. Manual Dexterity Frequently use a computer keyboard, PDA or other electronic devices. Audible/Visual Demands Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents. Environment Laboratory, Office and Manufacturing environments. Working at Amylin:
Full-time Amylin employees receive the following benefits:


Full Medical Coverage 'HRA and HSA options', Dental and Vision Plans, Disability, Basic Life and Accidental Death and Dismemberment Insurance, Optional Life Insurance, Flexible Spending Accounts, Paid Time Off, 401'K' Plan, Employee Stock Purchase Plan, Domestic Partner Coverage, Employee Assistance Program, Adoption Assistance, and Education Assistance

AMYLIN
Challenging Science. Changing Lives.

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