Batch Record Author

Ajinomoto Althea

San Diego,CA


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.Ajinomoto Bio-Pharma Services is currently seeking a Batch Record Author. 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 review of Non-GMP records are approved and then sent to client for billing.* Work with validation teams from both Aji 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.* Proven 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* Annual Company Shutdown in December* Comprehensive Medical, Dental + Vision* 401K Company Match + Immediate Vesting* Backup Daycare and Eldercare* Monthly Employee Appreciation Events and Food Truck Fridays* Employee Discount Programs* Tuition Reimbursement* Casual Dress Code* Wellness Programs* Community Outreach OpportunitiesIf you meet the requirements above, and would like to apply for this position, please visit our website at 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.Qualified M/F/D/V candidates are encouraged to apply.

Go Back