Quality Assurance Manager Kansas City, MO 64137 – Description: Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements. Essential Functions: supervision of quality assurance associates includes direction of daily activities as necessary, •Daily resolution of issues with quality assurance and internal, external clients. associates performance reviews for assigned associates. Provide performance reviews in both •Prepare oral and written form to associates. and release of documentation. •Review and approval of quality events such as deviations, investigations, document control and change •Review control. assurance review and approval of validation documents (IQ/OQ/PQ). •Quality assurance review of construction/facilities maintenance activities •Quality quality assurance SOPs. •Author deviations/investigations during manufacturing or packaging process and provide direction as •Identify to appropriate course of action. or assist in GMP training of associates. •Lead new associates as required. •Train packaging audits. •Perform deadlines according to agreed timeframes and communicate adjustments as needed. •Meet understanding of related SOPs, cGMPs necessary to accomplish daily tasks. •Clear and develop direct reports. •Mentor to company policies. •Adhere assigned meetings. •Attend Qualifications: Education and Experience: Bachelor’s degree in a scientific discipline with 5+ years of Quality Assurance experience in a GMP environment. LEAN, Six Sigma or ASQ certification preferred. Knowledge/Skills Requirements: Excellent verbal and written communication skills. • Lead by example according to Catalent's values and culture • Highly organized and attentive to detail. • Ability to lead teams and influence stakeholders. • Recognizes and address unmet needs within department. • Identify and quality improvement initiatives. • Collaborate with peers and demonstrate leadership capabilities in a matrix environment. •
Quality Assurance Manager Kansas City, MO – 64137 Description: Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements. Essential Functions: •Daily supervision of quality assurance associates includes direction of daily activities as necessary, resolution of issues with quality assurance and internal, external clients. •Prepare associates performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates. •Review and release of documentation. •Review and approval of quality events such as deviations, investigations, document control and change control. •Quality assurance review and approval of validation documents (IQ/OQ/PQ). •Quality assurance review of construction/facilities maintenance activities •Author quality assurance SOPs. •Identify deviations/investigations during manufacturing or packaging process and provide direction as to appropriate course of action. •Lead or assist in GMP training of associates. •Train new associates as required. •Perform packaging audits. •Meet deadlines according to agreed timeframes and communicate adjustments as needed. •Clear understanding of related SOPs, cGMPs necessary to accomplish daily tasks. •Mentor and develop direct reports. •Adhere to company policies. •Attend assigned meetings. Qualifications: Education and Experience: Bachelor’s degree in a scientific discipline with 5+ years of Quality Assurance experience in a GMP environment. LEAN, Six Sigma or ASQ certification preferred. Knowledge/Skills Requirements: • Excellent verbal and written communication skills. • Lead by example according to Catalent's values and culture • Highly organized and attentive to detail. • Ability to lead teams and influence stakeholders. • Recognizes and address unmet needs within department. • Identify and quality improvement initiatives. • Collaborate with peers and demonstrate leadership capabilities in a matrix environment.
jd_-_quality_assurance_manager_-_kc.docx