Supervisor, QC Raw Materials

Location
92121, San Diego
Posted
Dec 18, 2018
Required Education
Bachelors Degree
Position Type
Full time

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.

 

Together, Let’s Make A Difference.

 

Ajinomoto Bio-Pharma Services is currently seeking a Supervisor, QC Raw Materials. The QC Raw Materials department conducts routine and non-routine analysis, inspection, testing, review and release of raw materials and APIs, and completes all associated documentation accurately while collaborating with Supply Chain Management and Quality Assurance.

 

The Supervisor plans and manages workloads and priorities to align with company needs. Other key responsibilities include the implementation of cost savings and efficiency gain opportunities, interacting with contract testing labs and vendors to ensure material-related issues are resolved in a timely manner, and participation in client-facing projects.

 

Responsibilities:

 

  • Manages, develops & prioritizes work of QC Raw Materials team; develops next level leaders.
  • Ensures all raw materials requiring qualification are qualified in a timely manner and remain in a qualified state to ensure no manufacturing schedule disruptions.
  • Actively manages all contract test labs to reduce cycle time and holds labs accountable in deviation and OOS resolution within established Company resolution timelines.
  • Ensures regulatory and pharmacopiael compliance of all internal tests.
  • Ensures transition of retesting and release activities are migrated from current corporate ERP to current corporate LIMS within the agreed upon implementation phase window.
  • Develops and maintains department KPIs and metrics and supplies to Sr. Management on a monthly basis.
  • Actively supports and engages in the implementation of processes or workflow improvements with Supply Chain Management group to ensure timely release of all company raw materials.
  • Writes and reviews Raw Material Specifications, SOPs, Validation Protocols, Material Qualification Reports and Deviation Reports (DRs), as appropriate, using MasterControl electronic doc control system.
  • Leads out of specification (OOS) and deviation investigations, as appropriate, using acquired knowledge.
  • Participates in client meetings to determine material specifications and test requirements and assists in defining project parameters.
  • 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.

 

Leadership Responsibilities:

  • Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
  • Engages employees by creating a climate in which they want to do their best.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  • Maintains employee work schedules.
  • Provides oversight and direction to the employees in accordance with Aji Bio-Pharma’s policies and procedures.

 

Requirements:

  • Bachelor’s degree in a Life Sciences discipline or equivalent required.
  • Minimum of five (5) years of relevant experience in Quality Control of pharmaceuticals.
  • Minimum of one (1) year of experience in a functional leadership role.
  • Tactical expertise in QC Raw Materials. Ability to apply knowledge of materials and assays to problem solve across a wide range of data.
  • Familiarity with compendial requirements and navigation of USP-NF, EP and JP publications and websites related to raw materials; knowledge of relevant sections of 21 CFR parts 210 and 211.
  • Expertise in spectroscopy techniques for identification of raw materials preferred.
  • Detail oriented with strong written and verbal communication skills.
  • Demonstrated ability to follow detailed directions in a manufacturing environment.
  • Ability to work independently, within prescribed guidelines, or as a team member.

 

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section.  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.