Supervisor, Quality Control
Company: Quidel Corporation
Location: San Diego
Posted on: January 16, 2019
Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and wellbeing of people around the globe with well-known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, women's health, and virology.
The Supervisor, Quality Control is responsible for supervising a quality control department. Position is part of multi-shift supervisor team empowered to manage 24 hour testing and analysis operations. Position requires ability to jointly develop, implement, evaluate, and/or modify on going "best practices" to assure overall operational effectiveness.
Under minimal supervision this position is directly responsible for overseeing and managing daily quality control operations in support of manufacturing goals and company objectives. Position is responsible for assuring product is being assessed efficiently, cost effectively and according to production schedule. Position is responsible for following and assuring team compliance to all GMP's, safety, manufacturing and quality system procedures directly related to the manufacturing process and filling out the required supporting documentation associated with the products produced.
Responsible for the day to day direction of QC Analysts and and/or Technicians
Meeting production schedules, overall staff development, supporting product transfers and validations, and implementing training.
Participates in Lean Initiatives and activities
Initiating any necessary QIs, CAPAs or other investigations within the quality system.
Ensuring that the testing area is compliant with all required FDA, ISO and other applicable regulatory agency standards and documentation, as well as EHS, HR, Facilities, Housekeeping standards and requirements
Monitor product performance during the testing run; direct testing and/or analysis personnel and daily activities to achieve production goals.
Establish and maintain department metrics. Develop and initiate policies and/or procedures for continuous improvement of those metrics.
Train employees according to established procedures; maintain attendance and training records
Manage department expenses to achieve budget goals
Ensure that approved materials are available at all times to support production goals and timelines
Completion of daily cycle count program, oversee counting activities and prepare reports for management review
Assist when needed in both external and internal inventory audits
Responsible for the ongoing FDA/ISO compliant, cost-effective manufacture of specific products or sup-products
Review manufacturing records for accuracy and completeness in accordance with GMP
May be responsible for fulfillment of daily/weekly production schedules
Ensure that the test processes are set-up and operating in accordance with established procedures
Manages performance of staff towards department and Company goals, including but not limited to feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance.
Carries out duties in compliance with established business policies.
Education and Experience
Bachelor's degree in Chemistry, Biology, Engineering, related field or equivalent required
Five years of testing, analysis, or quality control/assurance experience with at least one to three years as a lead or supervisor role in laboratory environment required
Skills and Knowledge
Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
Experience in working with semi
Keywords: Quidel Corporation, San Diego , Supervisor, Quality Control, Other , San Diego, California
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