Compliance III Quality - GMP
- Ajinomoto Bio Pharma Services
- San Diego, CA
- Start date
- Mar 8, 2023
- Quality, Quality Assurance, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- 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 Compliance Associate III who will perform complex activities pertaining to assuring compliance with applicable regulatory requirements. This position independently hosts customer audits, leads internal and vendor audits, and reviews documentation for compliance with regulatory requirements.
· Contributes to customer audit program, including scheduling audits, hosting audits, communicating and coordinating with internal SMEs, responding to audit findings, and tracking completion of corrective actions.
· Contributes to internal audit program, including generating an audit schedule, conducting audits, writing audit reports, and evaluating responses to audit observations.
· Contributes to vendor quality program, including scheduling audits, conducting on-site and paper audits, writing audit reports, reviewing audit responses, maintaining an approved vendor list, tracking vendor quality issues, evaluating vendor change notifications, and establishing quality agreements.
· Reviews and approves quality management system SOP’s.
· Reviews and approves deviation reports and CAPAs related to quality systems.
· Participates in risk assessments and continuous improvement projects.
· Provides support during regulatory inspections.
· 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.
·Bachelor’s degree in Life Sciences discipline or equivalent experience required.
· Minimum of 4 years of experience in quality assurance.
· Good understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
· Strong understanding of internal requirements related to quality management systems, risk management, and supplier qualification.
· Developing skills in conducting effective quality audits.
· Effective in collaborating with internal and external customers and leading improvement projects.
· Detail-oriented with strong organizational skills.
· Proficient with Microsoft Office applications.
The anticipated hourly range for candidates who will work in California is $29.76 to $41.66.
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 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.
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. Our ultimate goal is to provide adaptive solutions, responsive service, trusted partnerships and peace of mind to our customers. Through innovation, accountability, compliance, communication and teamwork, we take pride in knowing our efforts are helping countless patients for years to come.
11040 Roselle St.
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