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Supervisor QC Laboratory at Mylan Inc

Posted in Other 30+ days ago.

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Type: Full Time
Location: Caguas, Puerto Rico





Job Description:

FOR US, IT\'S A MISSION
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

MAKE A DIFFERENCE
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:

* Under direction, plan, coordinate and supervise the implementation and maintenance of quality control systems at the laboratories. Using the standards, methods and procedures supervise the laboratory operations to assure that materials/products conform to appropriate standards of identity, strength, quality and purity. It includes oversee of timed execution of tasks such as: testing of materials/ products, investigation of aberrant data, assist on regulatory and PAI inspections, completion of regulatory commitments, tracking and trending, compliance initiatives, provides guidance to employees, personnel oversight issues, assist in hiring within group and continuous improvement projects.

* Supervise the laboratory team to achieve the established objectives and goals on a timely manner. Oversee the laboratory operations including control of the laboratory data/ results versus internal procedures, test methods and specifications, monitor the personnel performance in terms of quantity and quality of work, drive team for completion of new projects, monitor procedures and equipment performance in terms to the laboratory operations and business needs.
Review and/or verify the laboratory data/ results for accuracy and completeness as required per applicable procedures and/or test methods. Review chemical and physical testing data/ reports ensuring that materials/ products are tested in compliance with company specifications, policies and government regulations.
* Conduct internal audits (e.g. log books).

* Perform contemporary recording of laboratory data in respective logbooks, forms, laboratory work sheets, and/or computer systems, and supervise that team members follow these documentation practices. Recommend purchase of instrumentation and assist/ implement changes in procedures to meets the goals to effectively utilize personnel.

* Assist management in department planning. Perform the weekly testing schedule and assign the tests according to manufacturing and /or stability requirements or product deadlines. Attend to meetings and plan the laboratory tasks of the team in coordination with the Planning Department schedules to comply with business needs and metrics. Conduct lot disposition to meet the area performance metrics. Assist QC Manager in hiring of laboratory personnel. Plan and perform or supervise the training process of the laboratory personnel.

* Measure and control the workload and laboratory capacity to effectively meet multiple competing tasks. Control the
analytical data to identify quality performance trends. Control the reliability of the analytical equipment through the proper maintenance (at the team level) and housekeeping of the testing areas.

* Drive for continuous improvement activities, maintaining current with applicable regulations, standards and guidance documents. Approve Certificate of Analysis for release of lots to be distributed. Assist and/or perform the laboratory investigations which involves duties such as: write investigation reports, investigate the root cause, monitor and evaluate product trend & history, assess method validation, etc. Supervise and/or perform the implementation of correctives and preventive actions plans (CAPA).
* Write, edit and approve standard operating procedures. Perform changes to documents through the Change Control System, as applicable. (e.g. SOPs, specifications, methods, etc.) Coordinate the shipment of laboratory samples for external testing when tests cannot be performed in-house. Maintain awareness of employees safety and general working conditions required for Quality Control Laboratory. Conduct safety audits in the laboratory and drive safety/environmental activities. Supervise to comply with the Environmental Health and Safety practices/guidelines and current Good Manufacturing Practices.

MAKE OUR VALUES YOUR VALUES

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

* Minimum of a Bachelor's degree in Chemist (or equivalent) and 2-4 years of experience in the Pharmaceutical Industry. Experience in analytical techniques within the Pharmaceuticals Industry. Experience in the use and troubleshooting of instrumentation such as HPLC, FTIR, UV, GC and computers. Experience in technical writing and writing/ generation of laboratory investigations. However, a combination of experience and/or education will be taken into consideration. Proficiency in speaking, comprehending, reading and writing English is preferred.

* Licenses/ Certifications required: Puerto Rico Chemist License issued by the Puerto Rico State Department.

* Must possess knowledge of computer and appropriate software (e.g. MS Office, Empower, LIMS). Knowledge of a variety of analytical techniques such as: HPLC, GC, UV, titration, dissolution and others. Knowledge for the use and interpretation of pharmacopoeias (USP/NF, EP, JP).

* Must possess analytical thinking, problem solving and technical investigation skills. Ability to interpret data and provide directions to others in laboratory troubleshooting. Knowledge in cGMPs and proficiency in their appropriate application.
* Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.

WHY MYLAN?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

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.
Schedule:
Job Posting: May 21, 2019, 9:20:09 AM
Unposting Date: Ongoing.