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Nice Pak Associate Director, QC / Micro Labs in Orangeburg, New York

Description

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

To support the New York plant quality efforts through the effective management of all aspects related to quality and critical analytical impact associated with manufacturing of finished products. This includes the monitoring and achieving department metrics and cycle times with adherence and compliance to cGMP/USP/ ISO and FDA guidance’s and requirements.

The Associate Director, QC/ Micro Labs will lead efforts to ensure continuous laboratory improvement and productivity. This position will oversee and manage laboratory departmental budget requirements to ensure that all consumables are within established parameters and pursue any potential cost savings.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Managerial Skills:

  • Assure efficient allocation of resources and oversee day-to-day QC and Microbiology lab operational workflows.

  • Demonstrate management skills including delegation, time management, work allocation and people leadership.

  • Communicate and distribute work (raw, bulk, FG and stability) evenly between all three QC shifts; obtain clear status from every QC and Microbiology shift in a timely manner.

  • Communicate and report all status and any issues to other departments in a timely manner, as needed. Provide data interpretation and other assistance to other analysts as required.

  • Manage use of outside/contract labs for microbiology and/or analytical testing, as necessary.

  • Manage/Order, and/or monitor the purchase of laboratory supplies.

  • Strong leadership skills focusing on technical issue resolution, improved lab performance, effective collaboration, flexibility and multitasking of projects and priorities.

  • Act as strong coach and mentor focusing on team development, training, improved lab metrics.

  • Responsible for representing the QC and Microbiology labs and lab operations during regulatory inspections and customer audits.

  • Extensive and strong microbiological and analytical knowledge in performing investigations.

  • Establish, monitor, and improve critical KPIs in the Microbiology and QC labs related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.

  • Monitor expense budget in the QC and Microbiology labs and identify areas of cost savings initiatives.

  • Minimum of 10 years working in commercial QC labs (commercial experience preferred)

  • Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP products, with a minimum of 5 years of prior managerial experience managing different shifts

  • Prior experience in participating in regulatory audits and supporting audit findings

  • Excellent technical writing, verbal, and written communication skills

  • Excellent collaboration, trouble shooting, and problem-solving skills

  • Strong team player that can also work independently to achieve goals and objectives

  • Strong project management skills and ability to own cross functional projects and bring them to completion within the set due date

  • Strong computer skills with Word and Excel; experience with e-Systems is preferred

  • Ability to work effectively in a fast-paced environment with cross functional departments, own multiple projects and meet the assigned timelines

  • Support all remediation and continuous process improvement activities and plans.

    Testing, Reporting & Analysis:

  • Assure Test Methods, SOPs, Material Specifications, etc. are up-to-date and manuals are current.

  • Assure raw materials, in-process samples, finished products, complaint and stability samples are tested and released in a timely manner and all GMP documentation is completed correctly

  • Oversee adherence to Test Methods and Laboratory Procedures and oversee proper preparation, storage and use of all standards and solutions

  • Oversee and monitor Environmental Monitoring and testing schedule, progress, data/trending, and work quality

  • Approve and release product, raw materials, and other test results via current process (LIMS, etc.) in timely manner.

  • Ensure good documentation and data management practices are followed.

  • Ensure the QC and Microbiology labs are in compliance with all GMP requirements, and the labs are in an “Audit Ready State” at all times.

Lab Maintenance:

  • Troubleshoot instruments, lab equipment and ensure proper maintenance and calibration of all equipment and instrumentation. Keep equipment operating by certifying instrument performance; enforcing operating instructions; directing preventive maintenance; arranging for repairs; planning equipment replacement.

  • Schedule equipment repairs with outside vendors and ensure and document proper training of all analysts and conduct retraining of analysts as necessary.

TECHNICAL EXPERTISE:

  • Audit documentation, LIMS, laboratory practices, issue reports and coordinate correction of GMP deficiencies and oversee adherence to good laboratory practices and GMPs in the Microbiology and QC labs.

  • Participate, conduct and/or write OOS and Nonconformance/CAPA investigations and conduct audit of analytical testing documentation.

  • Assist in preparation of protocols, reports, procedures, logs, and other documentation as required.

  • Write and execute method transfer protocols on instrumentation as required.

  • Design and execute lab experiments with input from microbiologists, analysts and/or QA Management.

  • Keep accurate records related to testing activities and prepare summary reports of data in a timely manner.

    SPECIAL PROJECTS:

  • Assist in corporate and regulatory audits

  • Conduct special projects to further the objectives of the QC and Microbiology Laboratories as required

  • Assist with Annual Drug Product (APR) requirements

PERFORMANCE MEASUREMENTS

  • All raw materials, batches, and finished products shall be released in a timely manner.

  • Ensure all release of raw materials, batches, and finished products are done efficiently.

  • Maintain Lab cleanliness in a timely manner.

  • Ensure proper new / refresher training of Microbiologists and Analytical Chemists.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

  • Bachelor’s degree of Science in Biology, Chemistry or Analytical Chemistry with relative bench experience. Masters or Ph.D. in Microbiology is preferred

  • Advanced Graduate courses in desired.

REQUIRED KNOWLEDGE:

  • General knowledge of validation requirements, manufacturing processes, auditing, etc

  • In addition to normal academic educational requirements, chemistry education required. knowledge of GLP’s as it applies to laboratory techniques and systems processes, auditing, etc.

EXPERIENCE REQUIRED:

  • Must have Minimum 10-15 year’s in regulated pharmaceutical laboratory experience in microbiology, quality control and/or analytical departments, including prior supervisory experience.

  • Excellence in supporting FDA audits with items related to QC/Micro labs.

  • Experience in developing and executing validations for products, processes and equipment.

  • ISO certification experience beneficial but not necessary.

SKILLS/ABILITIES:

  • Strong decision making and problem solving capability;

  • Skilled in time management, planning and budgeting.;

  • Skilled in statistical data interpretation including process capability and microbial identification;

  • Excellent communication skills, both written and verbal;

  • Ability to handle confidential information in a professional manner

  • Strong analytical and microbiological investigational skills

WORKING CONDITIONS

  • No hazardous or significantly unpleasant conditions.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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