Quality Assurance Lot Disposition Manager

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 www.agcbio.com.

Summary:

AGC Biologics is seeking an energetic and highly motivated manager to join the QA Operations group as part of the lot disposition team. This role serves as a primary QA management review program for a team; evaluates and monitors ongoing compliance with established quality assurance processes and standards. Manage the reviewer of Manufacturing batch records, QC test data and other documentation supporting GMP operations and API lot disposition. Additionally, the position supports compliance through internal audits and regulatory inspection support.

Responsibilities:

• Participate in and facilitate regulatory inspection readiness.
• Recommends changes to policies and establishes procedures that affect immediate organization(s); manages development and implementation of tactical initiatives.
• Manages QA support for the review and approval of batch records.
• Review and approve less complex validation documents.
• Partner with other departments/groups to problem-solve and address moderately complex issues.
• Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing
• Disposition lots.
• Acts as advisor to less experienced colleagues to meet schedules and/or resolve technical problems.
• Review and approve executed batch records and product testing records.
• Routinely develops guidelines for less experienced employees to accomplish work independently.
• Collaborate in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation.
• Manages daily operations for a project/team comprised of professional employees.
• Management reviews to measure meeting of objectives.
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Review and approve moderated complexity deviations and associated corrective actions.
• May coach and develop team members on skill proficiency and performance with general direction on tasks and regular feedback.
• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Prioritizes and assigns technical resources internally and externally; ensures tasks are completed and work area/project goals and objectives are met.
• Coordinates and collaborates with other teams to meet organizational goals and work requirements.
• Represent QA in cross-functional project teams for moderately difficult projects.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and is able to identify viable and often innovative options.
• Uses analytical skills and judgment to recommend the "best" solution.

Requirements:

• Ability to interact constructively and efficiently with co-workers within and across departments.
• Excellent organizational skills and attention to detail.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Communicates decisions and recommendations with clear justification to the QA group and cross-functional areas.
• Begins to play a hand in the professional development of others; may mentor less experienced employees on job duties and general departmental operations.
• BS degree in Biology, Chemistry, or other relevant discipline or equivalent work experience
• Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Provide solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable ad consistent with organizational objectives.
• Provides direct supervision to professional individual contributors and/or skilled, support to individual contributors.
• Strong understanding GxPs (GMP preferred) and concepts in several quality systems.
• Demonstrates a strong understanding of procedures and methods for review function.
• Clear, concise writing skills and good verbal presentation skills.
• Minimally 8+ years of QA or related experience. An MS degree with 6+ years of industry experience
• Solves conflict and addresses workplace issues in a professional and collaborative manner
• Makes independent recommendations for routine operations.
• Works under only general direction. Independently determines and develops approaches to solutions.
• Good analytical skills.
• Understanding of basic scientific/technical concepts.

COMPENSATION RANGE:

$94,000.00 - $129,500.00

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.