Supplier Quality Associate, Ii-Senior

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, visitwww.agcbio.com.

JOB SUMMARY

The primary responsibilities of the Supplier Quality Associate includes executing the company Supplier Quality program.  Additional responsibilities for this role include administration of the supplier qualification processes, supporting the creation of new material part numbers, and related specifications, managing supplier related change controls and investigations and conducting supplier audits. This role requires the ability to work under minimal direction and possesses the ability to work on complex problems by analyzing procedures and data to create appropriate solutions. This role requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with internal and external partners. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Execute the AGC Biologics Approved Supplier Program for the Colorado manufacturing sites.
• Help develop the annual supplier audit schedule and schedule audits with suppliers
• Perform supplier audits and complete comprehensive, detailed audit reports in a timely manner, depending on associate level.
• Manage supplier CAPA follow-up.
• Facilitating initial and lifecycle supplier qualification assessments.
• Manage Approved Supplier List.
• Act as a supplier point of contact for quality related topics.
• Manage the assessment of supplier material change notifications and the resulting internal AGC changes, as needed.
• Work with internal technical authorities and Subject Matter Experts to investigate raw materials discrepancies.
• Follow up with supplier to ensure investigation progress, as needed.
• Support introduction of new raw materials into the GMP system, and materials specification changes.
• Create and revise controlled documents.
• Optimize the Supplier Quality program through management of or participation on continuous improvement projects.
• Supports regulatory inspections as an SME for Supplier Quality.
• May act as a delegate for Manager of Supplier Quality Management and other SQM Associates.

KNOWLEDGE, SKILLS, AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Substantial knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610.
• Understands compendia (USP/NF, PH. EUR., JP).
• Proven technical writing skills.
• Proven ability to perform supplier audits.
• Skill in verbal communications. Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
• Knowledge of Quality Assurance concepts related to raw material and supplier management activities.
• Knowledge of and skill in using computer software and hardware applications.
• Proficiency with Microsoft applications, including MS Word, MS Excel and Teams preferred.
• Skill in time and priority management. Must be able to work under general direction to manage team and complete work tasks.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.
• Ability to travel, on average approximately 15% of the time.

EDUCATION and/or EXPERIENCE 

Bachelor's degree (B.S.) or equivalent in chemistry, engineering or related life sciences field. 

Prior working experience in a Biotech/Pharmaceutical production environment is required, as required below:

• Associate II - Minimum 2 years
• Associate III - Minimum 5 years, preferably with at least 2 years focus on Supplier Quality
• Senior Associate - Minimum 8 years, preferably with at least 2 years focus on Supplier Quality
• Experience with change control principles and execution.
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• ASQ Certified Quality Auditor certification or equivalent strongly preferred.
• Experience with TrackWise preferred.

COMPENSATION RANGE: 

$59,760 - $115,390

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.