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Manager, Quality Assurance Laboratory

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Company :
Haemonetics Corporation

Location :
Covina, California

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

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Description :
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further Haemonetics is your employer of choice. Job Details Manager of Laboratory Quality Assurance is responsible for managing the QA laboratories and sterilization/stability programs and support all Drug product manufacturers, including CMO, to ensure that all practices and procedures comply with the current GMP s, GLP s, safety requirements, and other applicable standards. In addition, performs analytical activities employing traditional analytical methods and state-of-the-art instrumentation. Responsibilities/Essential Duties * Assist in the development of product specifications, testing to support IND/NDA submissions and study protocols all with appropriate laboratory documentation. * Conduct analytical development of new formulations and related assay methodologies. * Develop, perform and validate stability-indicating assays of sterile product. * Identify needs for analytical instrumentation and assists with procurement, qualification, and training. * Perform laboratory investigations and serve as the SME for functional areas. * Manage stability test protocols and perform associated analytical testing. Serve as SME for stability program and annual reporting requirements. * Monitor spending for laboratory supplies and labor utilization. * Perform and supervise the analytical testing of raw materials, in-process and finished products. * Supervise, coach, and develop technical staff. Perform performance reviews. * Perform laboratory investigations and peer reviews of scientific documentation. * Represent QA in regulatory, customer, and internal audits. * Identify lab test needs for new product development and changes to existing products. * Create product trending using analytical release data. * Manage chemistry and microbiological staff and testing processes to efficiently meet testing needs to support the Union production needs. * Maintain laboratory quality system procedures for compliance with current regulatory requirements and industry practices. Update procedures and processes to ensure compliance, and drive efficiencies. Supervisory Responsibilities * As a leader at Haemonetics, the Manager of Laboratory Quality Assurance will have 10 -12 direct reports and a minimum of 5 years managing and leading teams. Education * Bachelor of Science Biology/Microbiology or Chemistry Experience. * 5 to 7 years Experience with laboratory management. * 5 to 7 years of experience in Pharma and Medical devices: ISO 13485 and MDSAP, 21CFR820 and 21CFR210/211 * Extensive experience with laboratory investigations and methods validations. (Leadership) * 3-5 years Benchtop/hands-on experience with wet chemistry, lab equipment, or instruments. Skills * Strong understanding of quality practices applicable to the manufacture of combo products (medical devices and drugs) including customer and industry standards * Excellent knowledge of process validation and change management. * Understanding and interpretation of test data, scientific work-knowledge in product failure analysis * Possess knowledge of Statistical Process Control (SPC) * Bilingual (English / Spanish) is a plus * Familiarity with Lean Manufacturing, Manufacturing Process Control, Six Sigma methodologies EEO Policy Statement