QC Group Lead, Raw Materials
San Diego, CA 
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Job Description
QC Group Lead, Raw Materials
LocationSan Diego, CA
DepartmentQC Raw Materials - 650

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.

The QC Raw Materials Group Lead will utilize their QC technical and GMP experience while developing supervisory, mentoring and decision-making skills by leading one or more direct reports while aligning workload and priorities. This position may represent the department on inter-departmental alignment and/or Operational Excellence (OE) teams and will lead projects such as raw material qualification and Extractable/Leachable (E/L) projects. The Group Lead may also participate as a subject matter expert during regulatory and client audits and vendor qualification audits.

Responsibilities:
  • Leads training programs within QC; leads by example and mentors team members.
  • Conducts routine and non-routine analysis, inspection, testing, review, and release of raw materials and APIs under minimal supervision, using LIMS and QAD (an ERP system); completes all associated documentation accurately while collaborating with Materials Management and QA.
  • Writes and reviews Raw Material Specifications, SOPs, Validation Protocols, and Material Qualification Reports and Deviation Reports.
  • Gowning and raw material sampling in ISO class 7 cleanroom conditions.
  • Assigns in-house chemical identification testing by USP <191> methods, FTIR, FTNIR, and Raman IR.
  • Leads out of specification (OOS) and deviation investigations, as appropriate, using acquired knowledge.
  • May work closely with Project Managers on client-facing projects such as material qualification and Extractable/Leachable (E/L) projects.
  • Requests quotes from CTLs; arranges and/or assigns full monograph testing to compendial requirements.
  • May lead or assign team members in AQL inspections for defects in vials, syringes, stoppers and seals.
  • 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.
Requirements:
  • High School Diploma Required. Bachelor's degree in Chemistry or Life Sciences or equivalent preferred.
  • Minimum of four (4) years of experience in QC of pharmaceuticals; exhibits leadership potential.
  • 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.
  • Tactical expertise in QC Raw Materials. Ability to apply knowledge of materials and assays to problem solve across a wide range of data.
  • Proven ability to follow detailed directions in a GMP laboratory environment and has superior good documentation practices.
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.

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
  • 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


"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."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
4 years
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