Sr. QC Raw Materials Assistant

Location
92121, San Diego
Posted
Oct 02, 2018
Discipline
Quality, Quality Control
Required Education
High School or equivalent
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 Sr. QC Raw Materials Assistant primarily responsible for conducting routine analysis, inspection, testing, and release of raw materials and Active Pharmaceutical Ingredients (APIs) in a collaborative team environment, working closely with QC teammates and Quality Assurance (QA) team members to ensure that all required materials have been properly cleared for use in GMP production of clinical and commercial injectable drug products. The Sr. QC Assistant may represent the department on interdepartmental alignment teams, and may lead or support client-facing projects such as raw material qualification projects, as well as playing a supporting role in departmental initiatives for continuous improvement. The Sr. QC Assistant is expected to gain knowledge and experience towards a future role as a subject matter expert (SME) during regulatory and client audits and vendor qualification audits.

Responsibilities:

  • Conducts routine analysis, inspection, testing, review and release of raw materials samples under minimal supervision using LIMS and QAD (an ERP system); completes all associated documentation accurately while collaborating with Materials Management and QA.
  • Adheres to cGMP requirements and SOPs.
  • Gowning and raw material sampling in ISO class 7 cleanroom conditions.
  • Performs in-house chemical identification testing by USP <191> methods, FTIR, FTNIR and Raman IR.
  • Supports out of specification (OOS) and deviation investigations, as appropriate, with assistance from Group Lead or Supervisor.
  • May support Sr. QC Associate, Lead or Supervisor on client-facing projects such as material qualification projects; facilitates work through contract test labs to meet client needs.
  • Assists AQL inspections for defects in vials, syringes, stoppers and seals.
  • Writes and reviews product specifications as required.
  • Maintains lab area including routine cleaning of benches, biosafety cabinets, shelving and floors.
  • Collects and disposes of lab wastes according to established procedures.
  • Trains co-workers on QC methods and SOPs where appropriate.
  • 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 Ajinomoto Bio-Pharma Services’ cultural values and aligns daily actions with department goals and company culture.

Requirements:

  • High school diploma required. Bachelor’s degree in Chemistry, Life Sciences or equivalent experience preferred.
  • Minimum of two (2) years of experience with cGMP preferred.
  • Ability to apply knowledge of materials and assays to problem solve across a wide range of data with the guidance of more senior staff.
  • Has demonstrated ability to follow detailed directions in a GMP laboratory environment and has strong good documentation practices.

 

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.cmo.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.