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Sr. Quality Engineer

Employer
Ajinomoto Bio Pharma Services
Location
San Diego, CA
Start date
Nov 2, 2023

View more

Discipline
Engineering, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach

Why join Ajinomoto Bio-Pharma? 

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Sr Quality Engineer who will provide experienced Quality Assurance (QA) support from product development through cGMP clinical and commercial production. This individual provides QA On the Floor (QAOTF) and compliance oversight related to Facility & Engineering (F&E) activities for reliability and business continuity to ensure that client specifications production needs, and regulatory requirements are met. Independently reviews and approves technical documentation. Ensures operations comply with standard operating procedures, good manufacturing practices, and good documentation practices. Confirms safety and controls within multiple manufacturing departments. Identifies and assesses regulatory and quality risks in manufacturing activities and processes.  Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis to ensure compliance. Drives process improvements and enhancements. Leads projects and trains junior staff. Provides quality expertise and guidance to operational staff.

Responsibilities:

  • Oversees F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met.
  • Provide equipment, system, and facility validation /qualification guidance and ongoing support for established / validated processes
  • Leading cross-functional activities, in providing approach, methodology and deliverables.
  • Partnering with project teams to provide solutions for validation of systems following a risk-based approach.
  • Assist in developing and reviewing validation documents with functional teams, ensuring the documentation meets compliance requirements, quality standards, and current industry expectations.
  • Track and report status and progress of qualification activities or projects to direct manager and / or management review.
  • Identifies root causes of problems in the production process or as a result of investigations; recommends and/or implements corrective measures.
  • QA review and approver or risk assessments.
  • Quality point of contact for shutdown activities.
  • Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state
  • Perform investigations and implement corrective actions related to CAPAs and deviations
  • Representing Quality Engineering in an emerging industry.
  • 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 required (ChE, EE, IE, ME, CS, or similar) and 5+ years applicable cGMP experience in regulated industry,
  • Exceptions may be granted for equivalent work experience or graduate degree.
  • Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity.
  • Knowledge of Fill Finish and Biologics production environments preferred.
  • Familiarity working with electronic batch records.
  • Detail oriented and strong interpersonal and verbal communication skills.

The anticipated salary range for candidates who will work in California is $109,782.13 - $153,694.98

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

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 be asked to complete 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.

 

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