Qa Supervisor, Data Integrity

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 Supervisor, Lab Systems (Electronic Systems Support – ESS) who will be responsible for leading and overseeing activities of the ESS team, and providing technical guidance and insight on multiple projects concurrently including: LIMS, QAD, ACE, MODA and CPMS. This role works closely with other departments to align cross-functional needs and goals. The Supervisor is responsible for ensuring and promoting the highest levels of compliance and Data Integrity with regard to FDA and ICH guidelines.

Responsibilities:

• Design and implement software solutions to meet business needs in support of the paperless lab environment.
• Proactively research, recommend, and implement new ESS software and/or processes.
• Champions CGMP activities with oversight, guidance, and quality decision making, ensures ESSs are compliant with current Data Integrity regulations, guidance documents, and industry standards.
• Oversee scheduling of team functions to support GMP operations.
• Provide software configuration and customization direction/technical problem solving.
• Lead project meetings with internal stakeholders and communicate effectively on software requirements, implementation paths, validation, and documentation.
• Provides training to direct reports.
• Independently investigates, troubleshoots, and rectifies issues as a result of Quality and risk analysis. May be required to communicate to client partners.
• SME for regulatory inspections and client audits related to Quality oversight of ESS.
• Review, revise, create and approve ESS SOPs.
• Follow Ajinomoto Bio-Pharma Services’ EHS guidelines and promote safe working environment including ZIM (Zero Injury Mindset).
• 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 Life Sciences, Information Technology, or equivalent required.
• Minimum of 4 years of experience in software development or related function.
• Minimum of 3 years of experience working in a regulated life sciences industry.
• Minimum of 1-3 years of functional leadership or supervisory experience.
• Experience with GMP software qualification and validation according to USP, FDA, JP and EP guidelines.
• Working knowledge of software lifecycle and validation.
• Tactical thinker with excellent verbal and written communication.
• Strong knowledge of GXP regulations with a focus on 21CFR Part 11 including Data Integrity
• Advanced knowledge of Microsoft Office applications.

The anticipated hourly range for candidates who will work in California is $37.12 - $51.70

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.

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