QC Supervisor, Sample Management
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 and cell and gene therapies. 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 www.agcbio.com.
JOB SUMMARY
Manages a team of professionals. Oversees day-to-day quality control processes and teams; monitors compliance with established quality control processes and standards.
ESSENTIAL JOB DUTIES
- Oversee the day-to-day activities of a group within quality control.
- Supervise team to follow standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
- Identify issues that may interfere with quality specifications.
- Review QC team output for compliance with government and company standards and satisfy GMP regulations.
ESSENTIAL RESPONSIBILITIES
- Supervises daily operations for a project/team comprised of 8 support and/or professional employees.
- Provides technical leadership for LIMS, Sample Management, and QC shipping.
- Assists in the scheduling and review of product testing.
- Provides GMP oversight for the Sample Management program including review of logbooks and GMP paperwork associated with samples.
- Oversees maintenance of the QC CTUs in BMRAM for Sample Management.
- 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.
- Train, coach, and mentor team members on task and skill proficiency and performance with manager's guidance.
- Develop staff (i.e. set goals, assign development activities, review performance, etc.).
SCOPE
- Receives assignments in the form of objectives with goals and the guidelines to meet those goals.
- Provides direction to employees according to established policies and management guidance.
- Recommends changes to policies in a specific work area; supports development and implementation of tactical initiatives.
- Management reviews work to measure meeting of objectives.
JOB COMPLEXITY
- Works on issues where analysis of situation or data requires review of relevant factors.
- Exercises judgment within defined procedures and policies to determine appropriate action; solves moderately complex problems.
- Considers relative value of several alternative solutions to potential issues before making a recommendation to the path forward.
FUNCTIONAL KNOWLEDGE
- Requires solid understanding of the processes, procedures and systems to produce high-quality work on fairly standard problems within the discipline.
- Weighs alternatives, determines best approach to resolving problems and explains rationale to others; may serve as an escalation point for technical challenges.
DISCRETION
- Decisions impact the quality, efficiency, and effectiveness of own team; may impact closely related teams through quality of output and service provided.
INTERACTION
- Frequently interacts with subordinates and/or functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
- Networks with senior internal and external peers in own area of expertise.
SUPERVISION
- Oversees others by providing work direction and supervision, relying on manager for guidance.
- Will supervise 8 direct reports in Sample Management.
- Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
LEADERSHIP 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.
- Works across teams effectively.
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.
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.