Mgr Quality Control

Teva Pharmaceuticals

1d

About The Position

We Are TevaWe’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.The opportunityThis position is responsible for coordinating and managing all work associated with the various phases of the commercial production schedule and is responsible for planning and scheduling of raw materials, finished products, method transfer and special projects into the Quality Control (QC) testing sections as applicable. Additionally, this position will conduct and document laboratory investigations and execute projects. How you’ll spend your dayAll areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

Requirements

• Bachelor’s degree in chemistry or related scientific discipline or equivalent with a minimum of 5 years relevant progressive experience in a Quality Control laboratory environment.
• Minimum of 2 years of management experience in an environment supporting a production operation.
• Requires experience with an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires advanced understanding of the principles of analytical chemistry and/or microbiology as it applies to the responsible area.
• Advanced abilities related to technical writing and documentation activities. Able to design and document a process with little to no oversight.
• Advanced understanding of the fundamental principles and theory behind a variety of analytical techniques, including, but not limited to GC,FTIR, NEAR-IR, UV Spectroscopy and TOC.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP/Oracle and manufacturing/quality systems such as Trackwise/Veeva and Qdocs.
• Communicate effectively with excellent written and oral communication skills.
• Self-directed with ability to organize and prioritize work.
• Ability to identify the developmental needs of others and provide coaching, mentoring or encouragement to help others improve their knowledge or skills.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision making.
• Ability to analyze information and create metrics relevant to the business objectives.
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

Responsibilities

• Responsible for management and development of direct and indirect reports.
• Responsible for overseeing projects carried out by senior direct reports.
• Responsible for assisting and coordinating the initial and on-going training of analysts and technicians with regard to safety, regulatory and cGMP issues associated with working in the QC Laboratory.
• Responsible for prioritizing and coordinating testing of raw material, in-process, bulk product, packaged finished product, stability samples, micro samples, and/or water samples for analysts, as needed to support manufacturing. Assist in the checking/auditing of raw data and various logs generated by analysts.
• Responsible for liaising between QC functional groups (Finished Product, Raw Materials, Sampling, etc) and internal and external partners to set priorities and schedules to meet timelines.
• Responsible for generating a rolling daily/weekly Master Planning Schedule for Quality Control Lab based off the priority of Operations.
• Responsible for compiling QC Metrics (internal and corporate) and communicating within and above site as required.
• Responsible for conducting or coordinating the creation of Incident, Deviation and Out of Specification Investigation and Out of Trend Investigation reports.
• Responsible for assisting in maintenance of equipment and computerized systems as needed. This includes overseeing maintenance, qualification and GMP status of laboratory instruments needed for sample analysis or other analytical work.
• Responsible for performing complex revisions to Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for coordinating and designing activities associated with the stability program including sample management activities and data analyses and performing statistical analyses.
• Responsible for project management activities for certain projects related to capacity, efficiency, and utilization.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager