QA Associate I – Temporary

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 QA Associate I who is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Understanding and execution of basic cGMP and GDP principles is required.

Responsibilities:

· Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records.

· QMS process support for change controls and quality investigations.

· Performs AQL inspection of final filled product.

· Performs area line clearance operations in support of manufacturing operations.

· Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.

· Generate labels for cGMP use.

· Reviews, approves, and reconciles labels for cGMP use.

· Sterile gown qualified to support cGMP activities in sterile suites.

· Assists in the review and data entry of Calibration and Preventative Maintenance records.

· Assists in the review of equipment and facility related Change Control documentation.

· Maintains equipment files and archives.

· 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 Ai Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

Requirements :

· High School Diploma or equivalent required. Bachelor’s degree in a Life Sciences discipline preferred

· Zero to two (0-2) years of relevant experience in documentation, QA, or equivalent.

· Knowledge of cGMP regulations and good documentation practices preferred.

· Experience with Computerized Maintenance Management Software (CMMS) preferred.

· Demonstrated ability to follow detailed directions in a laboratory environment preferred.

· Ability to work independently, within prescribed guidelines, and as a team member

The anticipated hourly range for candidates who will work in California is $18.05 $25.27.

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.