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 Quality Engineer III CSV who is responsible for performing a wide variety of routine and semi-routine Quality Assurance (QA) support for CGMP operations, with a primary focus on QA oversight of Computer Systems Validation (CSV) activities. This individual participates in QA On the Floor (QAOTF) and compliance oversight activities related to Facility & Engineering (F&E) and Validation for reliability and business continuity to ensure that client specifications, production needs, and regulatory requirements are met. Independently reviews and approves technical documentation including validation documentation for electronic systems. Promotes a compliant and safe CGMP environment and follows SOPs and industry regulations and guidance documents. May participate in risk assessment and data governance activities. Ability to work independently, within prescribed guidelines, and as a team member. Leads projects and trains junior staff. This position is located in San Diego, CA and would be open to a hybrid schedule. Responsibilities:
- Assists in F&E activities in real time (QAOTF) to ensure compliance with internal procedures and global regulatory requirements are met.
- Performs Technical Quality Review and QA oversight of validation protocols, reports, and change controls (including E-System and Computer System Validation (CSV) activities.
- Assists in ensuring that technical documentation is accurate, compliant, and meets business objectives and client needs.
- Provides quality technical support for change controls and investigations. Ensures documented impact assessments are performed in a compliant manner and that regulated systems are maintained in a validated state.
- Assists in shutdown activities.
- Assists with internal, client and regulatory audits.
- Assists with the generation of department metrics.
- Assists with developing recommendations for continuous improvement projects.
- Assists in the review and approval of production batch records and associated data for product disposition.
- Assists in the review and approval of controlled documents including standard operating procedures, protocols, and reports.
- 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 in scientific or engineering discipline with 5-7 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, 820 & EU guidelines, and specifically EudraLex Volume 4 Annex 11,good documentation practices, and data integrity.
- Knowledge of Fill Finish and Biologics production environments preferred.
- Detail oriented and strong interpersonal and verbal communication skills.
The anticipated salary range for candidates who will work in California is $103,745.13 - $136,165.48. 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. For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO 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. #LI-KC1 #HP