Sr. Electronic Systems Support Analyst
3 weeks ago
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. Electronic Systems Support Analyst. This position supports the development, enhancement, and validation electronic Quality Management System (QMS) applications and related technology. The Sr. Analyst will collaborate with internal quality groups and manufacturing laboratories, Computer System Validation (CSV) as well as IT to develop and maintain solutions that provide a more efficient and compliant work environment. The Sr. Electronic Systems Support Analyst is an internal customer-interfacing position which requires a unique combination of computer systems knowledge and understanding of manufacturing and lab operations, computer system validation; specifically regulatory requirements set forth by the FDA/EU.
Responsibilities:
Provide daily technical support to QMS users in a timely fashion. Provide training to end users on various system processes. Ensure support tickets are up to date and accurate. Provide QA oversight to CSV activities including, but not limited to validation protocol and report review. Troubleshoot incidents reported by end users and through system logs and provide effective resolutions. Responsible for performing routine and non-routine operations within software systems such as activating/inactivating users, setting permissions appropriately based on account request form, configuring various software components within software for users to automate tasks and closing out associated tickets. Assist in the design, development, testing, documentation, and implementation of changes to production software. Assist in the configuration and maintenance of user accounts, analyses, calculations, lists, specifications, and many other core system objects. Author and edit QMS standard operating procedures. Consistently follow solution delivery lifecycle, company Standard Operating Procedures (SOP’s) and company policies at all times. Seek innovative ways to improve manufacturing and quality productivity via system functionality. Evaluates quality systems deployment and implements process improvements to decrease TAT on OOS, CAPAs, and deviations. Propose, champion, sponsor and/or participate in departmental and cross-functional operational excellence initiatives to facilitate company process improvement efforts. Gain and deploy cross-functional support from QA, QC, and IT departments for quality system operation improvements. Provide project management support for implementation of new processes within the electronic QMS. Serve as quality system subject matter expert for client and regulatory body inspections Develop view, standard queries, custom reports and dashboards based on requirements. 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 required. Minimum of two (2) years of experience in GMP regulated industry, with a background in IT related Quality Assurance, CSV or Software Validation. Minimum two (2) years of experience in electronic Quality Management Systems implementation and management. Electronic QMS integration experience with external systems desirable. Experience with Quality KPIs and electronic reporting from validated databases is required. Experience in management of information systems, including GMPs/GDPs. Effective time management through balancing multiple project responsibilities, ad-hoc customer requests and project-related activities and support. Detail oriented and strong written, verbal communication and presentation skills. Ability to work independently, within prescribed guidelines, or as a team member. Must be familiar with Microsoft Office applications and JReports is preferred.The anticipated hourly range for candidates who will work in California is $ - $
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.
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