Qa Supervisor Jobs

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

Essential Duties:

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

Qualifications

• Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
• At least 10 years Pharmaceutical/Medical Device cGMP quality experience
• Excels in organizational and leadership skills and attention to detail
• Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
• Bachelor degree in a scientific discipline
• Extensive knowledge of cGMP regulations and ICH guidelines.
• At least 3 years of supervisory experience
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners
• Qualified to work with controlled substances

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.