Quality Assurance Associate II - Investigations

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, holiday shutdown (December), paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

QA Associate II (1^st shift) – This role will support the Quality Assurance team by leading projects, training junior staff and coordinating daily activities with assistants. The ideal QA Associate II will provide quality oversight and support on the floor during manufacturing operations, as well as manage documentation review with junior staff and ensure documents are reviewed for completeness and accuracy. They will also assist in the review and approval of production batch records and associated data for product disposition.

Responsibilities:

• Manages the review of records and associated data in support of GMP operations activities (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records)
• Assists in the review and approval of internal production batch records and associated data for product disposition.
• Performs the review and data entry for calibration, preventative maintenance and validation activities.
• Supports the Red Tag and Asset Management Process.
• Executes QARM responsibilities.
• Designated subject matter expert during AQL inspection
• Processes Technical Quality documentation initiation, revisions, and deletions.
• Assists in the review and approval of executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product batches
• Performs real time, on -the-floor documentation review during commercial packaging and labeling activities.
• Sterile gown qualified to support cGMP activities in sterile suites.
• Oversees scheduled facility walk-throughs and material destruction.
• 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.

What we need from you:

• Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
• Minimum of two to four (2-4) years of experience in documentation, QA, or equivalent.
• Knowledge of cGMP regulations and good documentation practices preferred.
• Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade.
• Demonstrated ability to follow detailed directions in a laboratory environment.

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.

The anticipated hourly range for candidates who will work in California is $21.13 to $29.59.

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.

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.

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