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Supervisor, Quality Control

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Company :
Exact Sciences

Location :
Madison, Wisconsin

Expiry Date :
Mon, 05 Apr 2021 23:59:59 GMT

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Description :
Summary Of Major Responsibilities The Quality Control (QC) Supervisor will supervise, lead, train, and assist the QC team in a variety of QC functions, including but not limited to, raw material, in-process material, finished goods, and stability testing, process and method development, characterization and validation, and quality document generation. This position will be responsible for equipping, scheduling, and establishing systems for QC functions working closely with Quality Control Management and coordinating efforts. Essential Duties And Responsibilities – Analytical and functional testing of raw materials, intermediates, and finished goods in support of R & D, product and process characterization, the validation program, quality control, stability, and troubleshooting efforts. – Lead scheduling, monitoring, and reporting of laboratory activities. – Supervise, lead, develop, qualify, troubleshoot, and routinely perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics. – Provide subject matter operational expertise in Out of Specification and NCMR, Deviation report generation, and CAPA efforts. – Draft, review, and execute protocols supporting Process, Test Method Validation, and Stability Studies in accordance with internal procedures, cGMPs, FDA, and ICH guidelines. – Write and review quality documents; including, but not limited to, Standard Operating Procedures and test and inspection methods that are compliant with cGMP/GLP guidelines. – Provide representation or lead support of cross-functional teams and process improvements. – Lead project activities associated with QC. – Provide visibility and supporting information to assist management in prioritization, budgeting, resource management, and risk mitigation activities. – May support in the maintenance of performance and productivity metrics to drive process improvements, and ensure visibility to leadership and staff. – Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance. – Communicate goals clearly to employees to ensure understanding and success in achieving them. – Motivate and inspire employees to do their best work through coaching. – Maintain morale and support employee engagement initiatives. – Strong analytical and problem-solving skills. – Ability to make decisions with limited information and operate with autonomy. – Strong documentation with attention-to-detail and procedure writing skills suitable for a GMP environment. – Excellent oral and written communication and strong interpersonal skills. – Ability to develop, transfer, and thoroughly document new processes and production procedures. – Ability to interpret technical data and present findings to management. – Ability to work in a fast-paced, ever-changing environment. – Ability to organize, present, and convey complex problems or issues within and across other functions. – Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities. – Ability to supervise individuals or a team and overseeing multiple projects with a strong ability to troubleshoot issues. – Ability to support and comply with the company’s environmental health and safety procedures. – Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. – Support and comply with the company’s Quality Management System policies and procedures. – Regular and reliable attendance. – Ability to work designated schedule. – Ability to work nights and/or weekends as needed. – Ability to lift up to 50 pounds for approximately 5% of a typical working day. – Ability to utilize lab equipment for 80% of a typical working day. – Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. – Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height. – Ability to comply with any applicable personal protective equipment requirements. – Ability to work with hazardous or flammable materials (e.g., chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others. – Ability and means to travel between Madison locations. – Ability to travel 5% of working time away from work location, may include overnight/weekend travel. Qualifications Minimum Qualifications – Bachelor’s degree in Chemistry, Molecular Biology, or a science related field; or Associates degree and 2 years of relevant experience in Chemistry, Molecular Biology, or a science related field in lieu of Bachelor’s degree. – 5+ years of industry experience working with molecular and biochemical assays. – 1+ years of direct or indirect leadership experience. – Proficient in Microsoft Office. – Demonstrated professional knowledge with database, spreadsheets, and statistical programs. – Demonstrated professional knowledge of statistical and mathematical methods in biology/genetics. – Authorization to work in the United States without sponsorship. – Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications – 2+ years of direct leadership experience. – 1+ year of experience working in a biotech, preferably in a GMP and/or ISO13485, environment. – Demonstrated professional experience managing people in a GMP environment. – Strong documentation skills in accordance with GMP requirements. – Basic working knowledge with SAP. – Basic working knowledge of JMP software. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.