Supervisor, Quality Control

Location
San Diego, CA
Posted
Sep 21, 2020
Required Education
Bachelors Degree
Position Type
Full time

Together, Let’s Make A Difference.

 

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

 

Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

 

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

 

This position oversees routine and non-routine analysis of proteins, peptides, small molecules, large molecules, and ADCs in the QC Chemistry Department. Develops procedures to ensure quality control goals are obtained. Assures finished products conform to government and company standards and satisfy cGMP regulations. Regularly interacts with senior management on matters concerning functional area accomplishments, performance, needs, and issues.

 

Responsibilities:

  • Oversees in-process, release, and stability activities for buffers, intermediates, and finished drug product in the QC Chemistry Department.
  • Responsible for all applicable QAD input associated with release of finished goods.
  • Coordinates QC functions with operation activities and cross-departmental staff.
  • Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical report review and personnel training.
  • Interacts with clients and follows up on client inquiries. Serves as a liaison between the Company and auditors.
  • Oversees compendial testing, along with the implementation of new testing methods, including qualification and validation of test methods.
  • Analyzes data, technical reports, deviations, OOS investigations and test results and provides conclusions and proposals for future directions; capable of critical review.
  • Makes recommendations for corrective action necessary to assure conformity with quality specifications.
  • Responsible for meeting deadlines under a tight timeline and changing priorities.
  • Regular and reliable attendance on a full time basis (or in accordance with posted schedule).
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

 

Requirements :

  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Five plus (5+) years of relevant experience in Quality Control.
  • Minimum of one to three (1-3) years in a lead position in Quality Control
  • Two plus (2+) years of experience with method validations and Compendial testing and verifications
  • Working knowledge and experience with GMP regulations, good documentation practices, troubleshooting, and data entry.
  • Detail-oriented with strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a laboratory environment.
  • Must be proficient with Microsoft Office applications. Experience with electronic Quality Systems such as MasterControl, QAD, and LIMS preferred.

 

LEADERSHIP RESPONSIBILITIES:

  • Directs and provides expert knowledge in the day-to-day function of Quality Control.
  • Identifies, recruits, and retains top-notch talent.
  • Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
  • Coach, mentor, engage, and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
  • Provides oversight and direction to employees in accordance with Aji Bio-Pharma’s policies and procedures

 

 Please be sure to note where you saw our ad posting.

Successful Candidate must pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.