Drug Product Documentation Associate III
San Diego, CA 
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Posted 23 days ago
Job Description

Together, Let's Make A Difference.

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry's top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking a Drug Product Documentation Associate III. This position is responsible for the review of all drug product records for completeness and accuracy, to be sent to Quality Assurance for final review. The Documentation Associate will review, approve, package and send clients Non-GMP batch records for final release. The role will also work with Project Managers to author and /or revise existing drug product batch records for any changes to the projects along with correcting any document errors. In addition, the Associate will maintain group spread sheets on all in process projects. print vial and tray labels for the drug product group as needed, and assist in training any new hires.

Responsibilities:

  • Author and /or revise all client specific Batch Records for both clinical and commercial use.

  • Technical review of client batch record.

  • Ensure technical review of Non-GMP records are approved and then sent to client for billing.

  • Work with validation teams from both Aji Bio-Pharma and our client to author PPQ Batch Records for clients applying for commercial use of their drug.

  • Tracks and trends documentation issues as specified.

  • Maintains a GMP environment and follows all Standard Operating Procedures (SOP's).

  • 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 experience required.

  • Minimum of four (4) years of relevant experience in documentation, quality assurance or equivalent.

  • Ability to work independently or as a team member.

  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment

  • Must have a high level of skill using Microsoft Office applications.

  • Detail oriented and strong written and verbal communication skills.

We provide a Total Rewards package designed to make life better - both at work and at home.

  • Annual Bonus Opportunities for All Employees

  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off

  • Paid Parental Leave

  • Annual Company Shutdown in December

  • Comprehensive Medical, Dental + Vision

  • 401K Company Match + Immediate Vesting

  • Backup Daycare and Eldercare

  • Employee Appreciation Events

  • Employee Discount Programs

  • Tuition Reimbursement

  • Casual Dress Code

  • Wellness Programs

  • Community Outreach Opportunities

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.

Please be advised that Aji Bio-Pharma follows a comprehensive set of recruiting protocols and conducts interviews either in person or phone/via live video only. We will never use apps like RingCentral or other chat features to conduct an interview. The scammer is using an email account that looks like an Ajinomoto account but ending in .work in an attempt to fool individuals. We strongly recommend ignoring any request that looks suspicious or is unexpected. DO NOT CLICK ON ANY LINKS or provide any information in response to these scams. Please contact us at with any questions.


"We are an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4 years
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