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Job Details

QA Batch Release Associate III

Company name
Althea Technologies, Inc.

Location
San Diego, CA, United States

Employment Type
Full-Time

Industry
Sciences

Posted on
Sep 13, 2021

Valid Through
Dec 27, 2021

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Profile

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 QA Batch Release Associate III

who is

responsible for assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. Evaluates the impact of deviations and adverse events to product quality in support of batch release. Collaborates with internal team members to ensure compliance to specifications, processes, and procedures.

Responsibilities:

Investigates, troubleshoots, and rectifies issues as a result of QA analysis.

Evaluates overall product impact assessment for batch disposition and general investigations

Interacts with clients for the timely closure of investigations.

Evaluates and assess quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)

Independently generates and compiles lot file review documentation for batch disposition and updates status in ERP.

Facilitates the investigation of deviations and adverse events within cross functional teams.

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.

Minimum of three to five (3-5) years of relevant experience in batch release documentation review, investigation review, QA or equivalent

Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.

Knowledge of Fill Finish and Biologics production environments strongly preferred.

Detail oriented with strong written and verbal communication skills.

Ability to work independently, within prescribed guidelines, or as a team member.

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

Monthly Employee Appreciation Events and Food Truck Fridays

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.

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Company info

Althea Technologies, Inc.
Website : http://www.altheatech.com

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