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 QA Associate II, Quality Assurance Engineering is responsible for support of the following process and activities at the site:

PRINCIPAL RESPONSIBILITIES:

Support of AGC Equipment and Facility Management program.
Review and approval of equipment and facilities work orders, including calibration and routine and on-demand maintenance.
Review and approval of equipment on-boarding activities, including equipment siting, initial testing, and release for use.
Review and approval of Equipment use and maintenance procedures (Standard Operating Procedures and Work Instructions).
Review and approval of Equipment and Facility Qualification/Validation and Equipment and Facility Cleaning Validations, and support of the Equipment Requalification program.
Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.
Provide support during internal/clients audits and regulatory inspections.
Collaborate in the resolution of issues associated with the manufacturing operations, becoming the QA point-of-contact, providing guidance and facilitate the resume of manufacturing activities post deviation detection.

KNOWLEDGE, SKILLS & ABILITIES:

Strong technical and analytical understanding of Biologics Manufacturing and testing, with emphasis on facility and equipment Engineering processes.
Knowledge of Regulatory and Compliance principles and concepts (GMP) as they relate to Engineering processes.
Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques
Good organizational skills.
Demonstrated leadership in areas of teamwork and problem-solving.
Developing knowledge of regulatory and compliance principles and concepts as they relate to Engineering processing.
Ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Demonstrated ability to interact with cross-functional teams in order to ensure the compliance of the GMP operations at the site
Demonstrated strong understanding of procedures and methods for review function.
Understanding of basic scientific/technical concepts.

EDUCATION/EXPERIENCE:

BS degree in Engineering or equivalent work experience in an Facilities/Engineering role
3+ years of Engineering, Quality or Pharmaceutical manufacturing-related experience, including interpretation and application of regulatory principles as they relate to Engineering processes.

$29.00 - $39.50 hourly

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

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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Quality Assurance Associate II, Quality Engineering

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