QA Supervisor
Formerly Summit Biosciences Inc. | KDD
Date: 6 days ago
City: Lexington, KY
Contract type: Full time
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make:
Responsibilities:
Basic Qualifications:
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make:
Responsibilities:
- 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.
- Oversee the deviation and events management system.
- Develop and implement training qualification programs for QA team members.
- 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.
- Assist Manager with daily and project activities as needed.
- Maintain current knowledge of new regulatory developments.
- Other duties as assigned.
Basic Qualifications:
- Bachelor’s degree in a scientific discipline preferred
- At least 6 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
- Regular use of hands for documentation, equipment operation, and material handling
- Extended periods of standing and walking
- Ability to lift/move
- Full range of vision capabilities (close, distance, color, peripheral, depth)
- Must wear required PPE and follow cGMP/safety procedures
- Lift heavy equipment up to 60 pounds occasionally, climb ladders, and work in confined spaces.
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