Sr. Qa Associate - Qms Gmp

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 Sr QA Associate 1 who is the Quality Subject Matter Expert whom ensures manufacturing areas are maintained and in strict compliance. The associate independently reviews and approves lot file documentation, identifies/assesses regulatory and quality risks in manufacturing activities and processes, and independently investigates, troubleshoots, and rectifies issues as a result of QA analysis to drive process improvements and enhancements. The QA associate also leads projects, trains junior staff, and provides quality expertise and guidance to operational staff.

Responsibilities:

• Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
• Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices.
• Independently performs quality operations within multiple manufacturing departments
• Participates in multiple process improvement projects
• Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
• Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
• Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
• Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
• Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes.
• Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
• 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:

• High school diploma or equivalent required. Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required.

• Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent.
• Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity.
• Knowledge of Fill Finish and Biologics production environments preferred.
• Familiarity working with electronic batch records.
• Detail oriented and strong interpersonal and verbal communication skills.

The anticipated salary range for candidates who will work in California is $27.44- $38.41

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 be asked to complete 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.

#LI-KC1