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

 

SUMMARY: 

The QS Associate IV's 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 manufacturing site. 
  • Help develop the annual audit schedule. 
  • Schedule audits with suppliers. 
  • Perform supplier audits and complete audit reports in a timely manner. 
  • Manage timely performance and closure of outsourced audits, i.e. audits conducted via consultants and other internal qualified resources. 
  • 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 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 Quality. 
  • May act as a delegate for Manager 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. 

  • 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 change control principles and execution. 
  • Experience interacting with FDA or other regulatory agencies strongly preferred. 
  • ASQ certification or equivalent strongly preferred.  
  • Experience with TrackWise preferred. 

 

COMPENSATION RANGE: 

$85,100 - $108,000

 

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. 

Apply for this Job

* Required
  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at AGC Biologics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.