Senior Compliance Associate - Auditor

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. Compliance Associate I who will utilize their skills to hosts customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System.

Responsibilities:

• Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
• Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
• Supports the execution of internal audit program
• Supports risk management program
• Supports the continuous improvement of the Quality Management System
• Reviews and approves quality management system standard operating procedures (SOPs)
• Reviews and approves deviation reports and CAPAs related to quality systems
• Generates quality system metrics for management review meetings
• Trains team members on conducting internal and external audits
• 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 in a Life Sciences discipline or equivalent relevant experience required.
• Minimum of 6 years of relevant QA experience in a regulated industry.
• At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing Preferred.
• Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
• Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
• Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing.
• Detail-oriented with strong organizational skills.

The anticipated hourly range for candidates who will work in California is $35.43 - $46.50.

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.

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