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QC Raw Materials Associate II

Posted on: January 26, 2021 Apply Now
Experiential Learning, Full-Time Job Data & Technology, Healthcare, Pharmaceuticals, & Sciences, Natural Resources, Sustainability, & Environmental ScienceExpires February 26, 2021

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, 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 our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking a QC Raw Materials Associate II who will be 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 QC Associate II 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 QC Associate II 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 Aji Bio-Pharma’s 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 highly preferred.
  • Minimum of two (2) years of experience with cGMP high 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.

We provide a Total Rewards package designed to make life better – both at work and at home.

  • Annual Bonus Opportunities for All Employees
  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
  • Paid Parental Leave
  • Annual Company Shutdown in December
  • Comprehensive Medical, Dental + Vision
  • 401K Company Match + Immediate Vesting
  • Backup Daycare and Eldercare
  • Monthly Employee Appreciation Events and Food Truck Fridays
  • Employee Discount Programs
  • Tuition Reimbursement
  • Casual Dress Code
  • Wellness Programs
  • Community Outreach Opportunities

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.

New hires will 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Apply Now