Quality Systems Associate III, Supplier Quality Management
Company: AGC Biologics
Posted on: June 18, 2022
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.SummaryThe Quality Systems
Associate III primary responsibilities include executing the
company supplier quality program supporting a commercial drug
substance manufacturing site. Works on moderately complex problems
where analysis of situations or data requires an in-depth
evaluation of various factors. Additional responsibilities for this
role include administration of the supplier qualification
processes, supporting the creation of new material part codes and
related specifications and managing material related change
controls and investigations. This role requires attention to
detail, organization, multi-tasking, and comfort interacting
cross-functionally with internal and external partners. The
successful candidate is able to work under minimal direction and
possesses the ability to work on complex problems by analyzing
procedures and data to create appropriate solutions.Essential
Duties And Responsibilities
- Execute the AGC Biologics Approved Supplier Program for the
- Help develop the annual audit schedule.
- Schedule audits with suppliers.
- Perform supplier audits and complete audit reports in a timely
- Manage timely performance and closure of outsourced audits,
i.e. audits conducted via consultants and other internal qualified
- Manage supplier CAPA follow-up.
- Facilitating initial and lifecycle supplier qualification
- Manage Approved Supplier List.
- Act as a supplier point of contact for quality related
- Manage the assessment of vendor 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
- May act as a delegate for Manager Supplier Quality Management
and other SQM Associates. Knowledge, Skills, And AbilitiesTo
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
- Strong 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.
- Strong 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 complete work tasks.
- Demonstrated ability to work collaboratively to accomplish
deadlines and objectives. EDUCATION And/or EXPERIENCE
- Bachelor's degree (B.S.) or equivalent in chemistry,
engineering or related life sciences field.
- Minimum 5 years prior working experience in a
Biotech/Pharmaceutical production environment is required;
preferably with at least 2 years focus on supplier quality.
- Experience with CAPA.
- Experience interacting with FDA or other regulatory agencies
- ASQ certification or equivalent preferred.
- Experience with TrackWise preferred. Compensation Range$78,083
- $93,700AGC 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
Keywords: AGC Biologics, Boulder , Quality Systems Associate III, Supplier Quality Management, Executive , Boulder, Colorado
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