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Quality Control Supervisor

Company: Takeda Pharmaceutical Company Ltd
Location: Thousand Oaks
Posted on: November 23, 2021

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Plan, organize, supervise, and monitor the daily operations, activities, and workflow for the laboratory personnel in the Quality Control (QC) lab. Implement testing standards and policies. Ensure safety measures are followed. Assist laboratory personnel with career development and performance. Assist laboratory personnel in other areas as needed. Essential Duties and Responsibilities * Basic supervisory and leadership skills which includes supervising, planning, organizing, directing, and evaluating the day to day laboratory tasks, scheduling, staffing and recruitment, training, performance development and management and auditing activities for area of responsibility. * Ensure timely completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation. * Assist with the implementation and interpretation of applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications. * Develop and manage the performance of direct reports. * Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. Lead teams to resolve lab issues as needed. * Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and combination drug manufacturing labs. * Assist in plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations. * Lead technical reviews, investigations, and process improvement projects. * Identify, implement, and oversee changes within quality systems. * Assure equipment maintenance and calibration, and internal audits are performed on schedule. * Maintain expenses at or below budget for the lab. * Must have the ability to perform the responsibilities of the Supervisor II, QAIII or QC Manager on an as needed basis. * Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation. * Serve as a backup for the Supervisor II, QA III or QC Manager in handling Quality and Regulatory Inspections. * May also perform other duties as assigned. Qualifications * In-depth Knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures * In-depth knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices. * Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling. * In-depth knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems. * In-depth knowledge of quality systems including exception management, change control, document control, etc. * In-depth knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory * requirements pertinent to pharmaceutical and medical device manufacturing labs a plus. * Ability to write detailed investigation summary memos that consistently meet the requirements of the Quality Organization and the expectations of regulatory agencies. * Understand how to implement investigation strategies and apply root cause failure analysis. * Strong verbal and written communication skills. Must be able to read, write, and converse in English. * Must be a solid team player, able to meet deadlines and changing priorities. * Must be able to communicate effectively with managers, peers, and subordinates. * Must be very detailed oriented and able to produce high quality of work. * Must have good interpersonal skills and be able to work effectively and efficiently in a team environment. * Must have the ability to complete tasks with minimal direction from manager and/or supervisor. * Must have the ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines. * Laboratory management experience desirable/required. * Must have decision-making skills, technical problem-solving ability, and analytical skills. * Must have strong leadership, organizational and time management skills. * Basic Supervisory and Leadership skills required. * Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines. * Must be proficient in a variety of mathematical disciplines and be able to use and apply statistical tools. * Must be computer literate. Must be able to navigate electronic mail systems and the intranet for communication purposes. * Must be able to conduct searches and fill in on-line forums on a personal computer for the purposes of training, performance management, and self-service applications. * Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and PowerPoint) * Documented/Certified training in DMAIC and LEAN concepts a plus. * Passion for Improving Lives. Must be able to put our patients at the center of everything we do. * Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations. * Inspired Teams environment. Must be able to thrive in diverse high performing teams. * Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world. Education and/or experience * Bachelor's degree in Chemistry, Microbiology or Biological Science with analytical chemistry or laboratory coursework strongly preferred plus 1-3 years of experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment. Minimum of 0-2 years of leadership experience. Physical Demand * The overall physical exertion of this position is light work. * May be required to sit between 3-4 hours in AQC and Microbiology. * May be required to walk between 1-2 hours in AQ and Microbiology. * May be required to stand between 1-2 hours in AQC and Microbiology. * May be required to bend at the neck up to 1 hour in AQC and Microbiology. * May be required to bend at the waist for up to 1 hour in AQC and Microbiology. * Will not be required to squat in AQC and Microbiology. * May be required to climb (use step stools and ladders). * May be required to reach above/below the shoulder up to 1 hour in AQC and Microbiology. * Not required to kneel in AQC and Microbiology. * Not required to twist at the neck/waist in AQC and Microbiology. * May be required to lift to 10lbs in AQC and Microbiology. Will be required to lift between 5-10lbs less than 1x per shift. * May not be required to carry in AQC and Microbiology. * Requires use of both right and left hands and arms in AQC and Microbiology. * Requires repetitive use of both right and left hands between 1-2 hours in AQC and Microbiology. * May require simple grasping up to 1 hour in AQC and Microbiology. * Power grasping of dominant hand/arm is not required in AQ and Microbiology C. * May require fine manipulation up to 1 hour in AQC and Microbiology. * May require pushing/pulling with hands/arms up to 1 hour in AQC and Microbiology. * May require office work activities with hands/arms over 4 hours in AQC and Microbiology. * May be required to gown frequently and balance when gowning into clean areas. * May be required to drive cars, trucks, forklifts, or other equipment. * Will not be required to work around moving equipment and machinery. * Will not be required to walk on uneven ground or slippery surfaces in AQC and Microbiology. * Will not be exposed to noise above 85 dBA in AQC and Microbiology. Will not require hearing protection and other protective equipment to be worn. * Will not be exposed to hot, cold, wet environment/conditions in AQC and Microbiology. * May be exposed to dust, gases, chemicals, liquid Nitrogen, alcohols, acids, buffers, and fumes in AQC and Microbiology. Will not require respiratory protection. * Will not be required to work at heights above floor level in AQC and Microbiology. * Will not be required to operate foot controls or repetitive foot movement. * Will not require the use of special visual or auditory protective equipment in AQC and Microbiology. * May be required to work with biohazards and other hazardous materials such as: bloodborne pathogens, sewage, or medical waste in AQC and Microbiology (plasma samples or human-sourced materials, BSA and sharps). * May be required to drive to travel to other facilities, training sites, and off-site meetings. * May be required to work in confined areas. Working Environment * Laboratory environment. * Inside working conditions. * Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes. * Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes. * May be exposed to sunlight and heat. * Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in these work environments. * May work around chemicals such as alcohol, acids, buffers and other hazardous or biohazardous materials that may require special protection.May be required to work in a confined area as defined by the Environmental, Health, & Safety office. * May work around Methotrexate, which is a known cell growth inhibitor. * May require immunization before performing work within the manufacturing area. * May be around moving equipment and machinery. * Possible exposure to cool/hot storage conditions. * May work in a cold, wet environment. * May be exposed to dust, gases, and fumes. * May be working in a loud area that requires hearing protection and other protective equipment to be worn. * May be required to travel for business reasons, e.g. training and meetings. * Must be able to read, write, and converse in English. * Must be able to work more than 8 hours a day or 40 hours a workweek as required. * Overtime may be required at times. * Will be required to work an alternate work schedule (10 hour shift / 4 days a week). * May be required to work or be assigned to a different shift as needed. * Maybe required to work weekends and holidays. * Will interact with other people. * Pace may be fast and job completion demands may be high. This job posting excludes CO applicants. #GMSGQ #ZR1 #LI-MA1 EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - CA - Thousand Oaks - Rancho Conejo Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical Company Ltd, Thousand Oaks , Quality Control Supervisor, Other , Thousand Oaks, California

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