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:

The Quality Assurance (QA) Scientist I will provide quality oversight of the Quality Control (QC) department to ensure compliance with all standards, procedures, and regulations.  Responsible for the QA review and approval of SOPs, Methods, Deviations, Laboratory Investigations, Change Controls, Method Validation and Equipment Qualification activities related to the QC department.  May lead projects or represent QA interests in multidisciplinary project teams. 

 

KEY RESPONSIBILIES:

  • Provide QA oversight for quality control activities, including review/approval of methods, stability protocols/reports, and certificate of analyses.
  • Supports the QA review and approval of method validation, method transfer, and equipment qualification activities related to the quality control laboratories.
  • Acts as QA approver for quality system records, such as Change Controls, Deviations, CAPA and Laboratory Investigations.
  • Partners with QC and other departments for root cause analysis, problem solving and implementing corrective and preventive actions.
  • Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
  • Accountable for decisions and results that ensure timelines are met.
  • Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.
  • Works closely with other team members in a cooperative fashion to ensure project progression.
  • May participate in internal/external audits and regulatory inspections.
  • Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Understanding of Biologics Manufacturing and Quality Control Testing in a GMP facility.
  • Knowledge of scientific principles and concepts as they relate to Quality Control and GMP.
  • Knowledge of CAPA, change control and deviation programs and requirements.
  • Great team player who is collaborative and positive.
  • Ability to understand and apply GMP regulations as they relate to QC and Quality Systems.
  • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
  • Strong interpersonal, written/oral communication and problem solving skills.
  • Experience with regulatory inspections, internal/external audits.

 

EDUCATION/EXPERIENCE:

  • BA or BS with at least 5 years QA-related experience or equivalent work experience or a PhD in a scientific discipline with at least 2 years related experience; may include post-doctoral experience or equivalent work experience.
  • Equivalent education and experience may substitute for stated requirements.

 

COMPENSATION RANGE:

$83,920 - $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.

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