Supervisor, Quality Assurance
Location
Boulder, CO | United States
Job description
COMPANY SUMMARY
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, on time. For more information, visit
JOB SUMMARY
The Supervisor, Quality Assurance In-Plant position is responsible for the oversight of the day-to-day activities of the In-Plant Quality Operations team. This position requires the ability to work under minimal direction, strong technical knowledge of manufacturing processes and quality regulations, the ability to work on complex problems, attention to detail, organization, and comfort interacting with personnel within all levels of the organization.
KEY RESPONSIBILIES:
- Provide direct supervision to QA In-Plant team and supervises daily/weekly tasks
- Demonstrate strong understanding of, and compliance with, procedures to support GMP compliance
- Coordinate and/or review executed batch records and associated documents, product testing records, logbooks, work orders, etc. for completeness, compliance
- Review documentation supporting GMP operations
- Assist with investigations and resolution of manufacturing, equipment, or facilities related deviations
- Review and approve Minor deviations and CAPA, may review and approve Major deviations
- Partner with other departments/groups to address routine operational issues and escalate more complex issues
- Partner with other departments to proactively address GMP compliance concerns and resolve problems
- Represent QA in cross-functional project teams for relatively straight-forward projects with less challenging clients
- Provides technical leadership in a specific work area
- Prioritizes and assigns project goals; ensures tasks are completed and work area goals are met.
- Coordinates with other supervisors and teams to meet the business need and output requirements
- May coach team members on task and skill proficiency and performance with manager's guidance
- Performance management and appraisals
- Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES: - Strong verbal and written communications skills.
- Applies understanding of how the team relates to other related areas to improve efficiency of own team.
- Recognizes performance improvements and conveys feedback constructively.
- Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company.
- Well organized, flexible, and responsive.
- Good judgement with strong interpersonal relationship, team building, and collaboration skills
EDUCATION/EXPERIENCE: - BS/BA degree with 5+ years of industry experience, or Master's degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
- Previous managerial experience preferred, but not required.
- Prior experience with biologics manufacturing preferred.
- Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
Compensation Range:
$83,920 - $115,390 Based on experienced
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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