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.
This position of Quality Systems Associate includes ownership of Quality Systems; including Deviation, Corrective and Preventive Action (CAPA), Change Control, Quality Management Review, etc. Specifically, the role will manage Quality Systems and site electronic Quality Management System (QMS), train employees on use of systems and maintain site metrics. This position requires staff to work on moderate to highly complex problems where analysis of situations or data requires an in-depth evaluation of various factors. This role requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent. The Quality System Associate 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
- Site subject matter expert on AGC Biologics Quality Systems (i.e. Deviation, CAPA, Change Control) and electronic QMS.
- Leads Quality Event triage and root cause analysis sessions to ensure direct and systemic root cause is identified for deviations.
- Provides training in investigation and root cause analysis techniques and best practices.
- Monitors Quality Systems and reports metrics regarding the health of the systems.
- Supports Change Control Review Board.
- Leads continuous improvement projects.
- Manages input into Annual Product Quality Review (APQR).
- Manage Site Quality Plan.
- Supports other Quality Systems (i.e. Training, Supplier Quality Management, Document Control), as needed.
- Supports Data Integrity initiatives, as needed.
- Support Complaints and Recalls, as needed.
- Maintains SOPs and other GMP documents as needed to support Quality System programs.
- Supports regulatory inspections as an SME for Quality Systems. May support or lead Internal Audits.
- May act as a delegate for other Quality System Associates (all levels) and for Director Quality Systems with respect to topics related to Quality Systems.
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.
- Proven technical writing skills.
- Proven ability to conduct root cause analysis and risk assessments.
- 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 processes and compliance.
- Ability to independently determine and develop approaches to address simple to complex issues.
- 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.
- Prior experience working in a Biotech/Pharmaceutical production environment is required:
- Quality Systems Associate III - Minimum 5 years with at least 2 years’ experience working with Quality Systems
- Quality Systems Associate, Senior - Minimum 8 years with at least 3 years’ experience working with Quality Systems
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Experience with TrackWise preferred.
$74,960 - $129,250
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.