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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Rochester Quality Assurance Team Lead is responsible for coordinating the day to day operations of the Quality Assurance team. This role provides leadership and expertise to assist in investigation and closure of manufacturing deviations, lot release activities, quality assurance floor support and coordination of QA resources with manufacturing activities. The Team Lead role represents the quality assurance unit or the entire quality organization on high complexity projects and project teams both within and outside of Quality Operations. The Team Lead role also will leads medium to high complexity project teams within Quality Operations tasked with improving laboratory or other quality systems. This role has the responsibility of serving as Management Designee during Manager absences. The Team Lead may present and potentially defend QO Quality Systems during audits and inspections.
• Support robust investigation into manufacturing deviations and facilitates timely identification of root cause and closure of the deviation.
• Support lot release activites including batch record review as needed.
• Directs Quality Assurance resources to ensure that manufacturing and site quality priorities are being met.
• Independently writes and/or reviews SOPs, technical reports, project plans, etc.
• Demonstrates complete knowledge of quality and manufacturing operations including both technical and compliance aspects.
• Demonstrates understanding of current aseptic manufacturing best practices.
• Serves as the point person for all customer interactions with quality assurance which includes attending scheduling meetings, communicating priorities to the QA team, and following up with customers on the status of priority status.
• Leads implementation of quality assurance continuous improvement initiatives.
• May serve as management designee during Lab Manager absences.
• May also present/defend QA Quality Systems during audits/inspections.
Education: BA/BS, or MS in Chemistry, Biochemistry, microbiology, or related science preferred with a minimum of 5 years related experience in Quality Operations.
Experience: Minimum experience in a cGMP environment, as described above, with a strong working knowledge of a variety of quality systems and processes. Prior experience in a people management role strongly preferred. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. The candidate must have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review.
Communication: Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
Reasoning Ability: Strong analytical and problem solving abilities.
Technical: Comprehensive understanding of cGMP guidelines outlined in CFR. Knowlegde and demonstrated ability to apply the company Quality Standards to ensure loacal practices and procedures reflect these requirements. Independently writes SOPs, technical reports, project plans, instrument qualifications, etc. Basic understanding of aseptic manufacturing highly desirable.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must not have a Penicillin allergy.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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