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Manager, Analytical Quality Control

Piramal Pharma Solutions

This is a Full-time position in Lexington, KY posted June 6, 2021.

PURPOSE OF THE ROLE The Analytical Quality Control Manager coordinates the work of team members performing material sampling, testing, release, and stability programs, as well as maintain the lab and equipment in compliance with cGMP regulations.

KEY RESPONSIBILITIES * Direct and coordinate the Analytical Quality Control group.* Lead and mentor individual group members.* Assign department resources so that company goals/timelines are met.* Develop and manage department budget.* Oversee training activities for department* Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance and calibration* Ensure suitable procedures (SOP’s) are in effect within the department and are compliant with current regulatory requirements.* Oversee all quality investigations within the department (deviations, CAPA and LIR)* Monitor and evaluate key performance metrics and communicate them to management.* Oversee material specification, sampling, and qualification programs.* Provide leadership in quality control testing and release program to support manufacturing activities.* Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed* Ensure suitable laboratory safety procedures are in place.

* Ensure that department technical expertise and capabilities are constantly evolving and current with industry.* Maintain the department’s documentation practice compliance with cGMP and regulatory requirements.* Encourage an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety* Continually review programs and systems to develop and drive improvements in efficiency, effectiveness and quality.* Develop the Materials testing Training program for QC analysts and lead the training activities.

* Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other project or material specific documentation with particular attention to accurate record keeping.* Ensure Lab Sustain Permanent Inspection Readiness (PIR) Education Requirements:
· BS degree required, preferred in chemistry or pharmaceutical science.

WORK Experience: * 10 years’ working within quality control, 5 years of formal management/leadership * Experience working with potent, cytotoxic, radioactive and biological materials, parenteral drug products strongly preferred* Contract manufacturing strongly preferred Functional OR TECHNICAL Skills: * High proficiency in technical writing and documentation * Ability to communicate effectively and interact with multi-disciplinary teams* Excellent organizational and planning skills* Strong working knowledge of FDA and EU GMP regulations.

* Ability to make independent decisions regarding Quality related concerns or issues * High level of proficiency operating all Microsoft Office applications* Six Sigma Green Belt, Benchmarking and Project Management experience * Demonstrated ability to lead a team PHYSICAL DEMANDS * Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.* Long periods of standing and walking * This position may require long periods of sitting, typing, computer entry or looking at a computer* Must use hands to handle, feel, reach, type or operate objects or controls WORK ENVIROMENT * Ability to work in an office and analytical laboratory setting* Position may require some extended hours including evenings and weekends to support 24×7 manufacturing activities* Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.* Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.

EQUAL EMPLOYMENT OPPORTUNITY Piramal Pharma Solutions is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.