Supervisor Quality Control

Description

Job Summary:

This position is responsible for one or more of the following activities in the Quality Control Department: Testing of in-process samples, final products, raw materials, components, microbial, and stability program (testing and reporting) samples. Administer all computerized quality systems in the lab including chromatographic data systems. Supports process validation activities. Supervises method transfers and supports method validation for analytical development. Maintains systems for cGMP compliance.

Job Responsibilities

• Supervises quality control analysts and ensures their training and annual review.
• Allocates testing schedules to ensure timely release of analytical results to meet production and stability schedules.
• Approves data packages and release of analytical results.
• Maintains thorough understanding of all Quality Control STPs, SOPs and data acquisition systems.
• Initiates, reviews, and refines Quality Control STPs, specifications, and SOPs.
• Works with production managers to meet manufacturing needs.
• Works with Quality Assurance and Technical Services for all Process Validation Projects and compliance issues.
• Creates and reviews protocols/reports, including instrument calibrations, IQ/OQ/PQ.
• Authors, reviews, supports and supervises laboratory investigations.
• Coordinates and executes method validations and method transfer from/to Quality Control.
• Maintains a technical expertise in analytical laboratory instrumentation.
• May be assigned to administer the stability program for non-commercial and commercial products. This includes but not limited to: creating study protocols and reports, writing annual stability reports; evaluating stability data; working with off-site contractors to complete stability testing, monitoring stability chambers, coordinating the stability testing as per protocols and informing management of any stability failure.
• Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:
• Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes;
• Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy;
• Effectively managing performance for direct reports according to the Performance Management Program,
• Attracting and retaining talent based on our talent management framework;
• Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions;
• Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
• Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
• Works as a member of a team to achieve all outcomes;
• Leads with a mindset that respects all cultural dimensions;
• Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
• All other duties as assigned.
  
  

Qualifications

Job Requirements

• Bachelor's degree (B. S.) in chemistry or related field or Master's degree (M.S.) in chemistry
• Knowledge, Skills and Abilities
• Hands-on experience on HPLCs, GCs, Dissolution Apparatus, Balances, Spectrophotometers, Autoclaves, Laminar Flood Hoods, Stability Chambers, Incubators and Physical Testing Instruments (for pH, adhesion, peel, etc). Strong knowledge of chromatographic data management systems (i.e., Empower). Knowledge of the Stability Programs and current regulations. Experience with TrackWise and LIMS systems.
• FDA, cGMPs, and SOPs related to job requirements.
• Mathematical Skills:
• Ability to comprehend and apply principles of basic mathematics and statistical theory. Ability to work with concepts such as limits, ranges, and numerical specifications.
• Reasoning Ability:
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Strong troubleshooting and analytical skills. Ability to conduct unbiased, scientifically sound laboratory investigations in a timely manner.
• Language Skills:
• Ability to read, analyze, and interpret common scientific and technical journals, Pharmacopoeias, specifications, standard operating procedures, and standard testing procedures. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write reports, business correspondence, and procedures that conform to prescribed style and format. Ability to effectively present information to upper management and other groups.
• Experience
• B.S. degree 7-10 years of progressively related experience and a minimum of 3 years as a Senior QC-Analyst or a higher supervisory related experience.
• M.S. degree 5-7 years of progressively related experience and a minimum of 2 years as a Senior QC-Analyst or a higher supervisory related experience.