at Mylan Inc. in Rockford, Illinois, United States
Job Description
Mylan Institutional Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the QC Operations Associate role will make an impact:
Key responsibilities for this role include:
Know and comply with all applicable Standard Operating Procedures (SOPs) and Work Instructions (WI). Create, review, recommend, and revise SOP(s) and Work Instructions (WI) as required.
Maintain a safe, clean and organized work environment to established 6S Standards. Practice safe lifting and carrying in accordance to EH&S guidelines. Keep all equipment (machines, tools, work stations, and storage units) organized and in good condition.
Assure that the non-controlled Retention Cage remains locked at all times and that only authorized personnel are allowed access. Prepare and store retention samples in accordance to all applicable SOP(s) and/or WI as required. Issue and maintain Cage Entry log books, complete required computer entries for samples database. Coordinate and ensure completion of Retention Sample Visual audit and inventory as required in accordance to all applicable SOP(s) and/or WI. Maintain all pertinent Retention and Testing records.
Perform monthly destruction of retention according to the expiration date in accordance to all applicable SOP(s) and/or WI.
Complete temperature and humidity readings and maintain temperature and humidity charts. If temperature or humidity excursions observed, ensure that the appropriate investigation is conducted and maintain records. Prepare monthly and year-end summary of all readings.
Provide support for the annual product report (APR).
Provide support for internal audits and internal audit responses.
Assure all testing samples are properly packed and shipped domestically and internationally.
Be an active member in site improvement projects, helping to streamline the process, maximize efficiencies, eliminate waste and help implement improvements to achieve company goals. (i.e. Kaizen events, 6S audits, etc).
Support continuous improvement efforts to achieve company goals.
Perform other duties as assigned by the Senior Manager, QC Operations.
The minimum qualifications for this role are:
Must possess knowledge of pharmaceutical industry or related fields.
Must possess strong computer, organizational, clerical, mathematical/statistical skills and good oral and written communication skills. Must be knowledgeable of the SAP system.
Minimum of an Associate's degree/college diploma (or equivalent), degree in Science or Science related field and 1-2 years of Data review, USP, ICH Guidelines experience, required. However, a combination of experience and/or education will be taken into consideration.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
Ability to add, subtract, multiply and divide.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
Moderate physical demand. Continuous/frequent lifting/moving average weight (25 to 50 lbs./11-27 kgs) and occasionally lifting heavy weight materials or strenuous activity.
Typically sitting at a desk or table, or walking through the manufacturing plant. Must be able to intermittently stand, walk, bend, stoop, kneel and climb stairs. May require use of hands and arms. Repetitive Computer entry/typing
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment... For full info follow application link.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â