QA Supervisor

Job Details

Level Experienced

Job Location Company Headquarters - Lexington, KY

Position Type Full Time

Education Level 4 Year Degree

Job Shift Day

Job Category Pharmaceutical

Description

Summary:

Responsible for providing quality oversight during all stages of pharmaceutical development, manufacturing and testing.

Essential Duties: Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures Leads the day-to-day activities of the QA group with respect to the writing, review and approval of GMP documentation. Participate in all plant activities and leads continuous improvement objectives to ensure cGMP compliance. Advises management on findings and recommendations related to internal and external auditing and implements changes Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents. Develops and maintains metrics and trending reports for Compliance-related activities. Reviews and approves product complaint investigations and assists with investigations. Leads activities associated with various one-time or on-going projects (from participation level to project manager). Collaborates with departments and external suppliers regarding quality concerns. Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.). Leads regulatory inspections and customer audits. Assists Manager with daily and project activities as needed. Maintain current knowledge of new regulatory developments. Other duties as assigned.

Qualifications

Bachelor degree in a scientific discipline At least 9 years Pharmaceutical/Medical Device cGMP quality experience Excels in organizational and leadership skills and attention to detail Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization Familiar with the necessary components of facility qualification and validation activities. Extensive knowledge of cGMP regulations and ICH guidelines. Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners Ability to work in a lean, action oriented organization and demonstrate a strong work ethic Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team Qualified to work with controlled substances

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