lims BA (loa)CGI

Position Description: The Laboratory Operations Analyst should have 4-8 years of experience in Pharmaceutical, Biotech, and/or Medical Device Commercial Laboratory Operations. He/she must have experience contributing to projects and/or leading proje Position Description: The Laboratory Operations Analyst should have 4-8 years of experience in Pharmaceutical, Biotech, and/or Medical Device Commercial Laboratory Operations. He/she must have experience contributing to projects and/or leading project workstreams in GxP environments. He or she must be comfortable and proficient in interacting directly with clients on an ongoing basis and managing their expectations. In addition, the candidate should be adept at eliciting business requirements, translating business requirements into system requirements, and managing clarifications between business and technical teams. Experience with Computer Systems Validation (CSV) and the Solution Delivery Lifecycle (SDLC) are also key qualifications. Your future duties and responsibilities: . Provides subject-matter expertise and support to Quality & Manufacturing Project and Business Development teams as needed in the following areas: . Laboratory Information Management Systems . Sample Receipt / Management . Standards & Reagents . Chemical Inventory Management . Dispositioning . Stability . Electronic Lab Notebooks . Laboratory Equipment Management Systems (Empower, Blue Mountain, etc) . Application Lifecycle Management Systems (ALM) . Drafting, Approving, and Executing Test Scripts in ALM Systems . Contributing to the development of Requirement Traceability Matrices in ALM Systems . Demonstrates facility in client-facing activities including: . Eliciting and documenting business requirements. . Analyzing and verifying business requirements. . Translating business requirements into system and non-functional requirements. . Facilitating requirements review sessions with business and IT. . Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material define supporting procedures and standards document training materials assist in the immediate training effort etc.). . Assists in the creation of business cases and other related financial planning, impact identification, or value justification. . Consistently delivers on the following internal activities while fostering a collaborative environment: . Maintains and manages requirements within requirements management tool and related SDLC artifacts. . Performs or assists with defect or incident root cause analysis in support of incident and problem management processes. . Performs or assists with other functions including vendor coordination, planning, project management, release management and change management as assigned and actively participates in special projects as assigned. . Adheres to Solution Delivery Lifecycle (SDLC) and IT Service Management (ITSM) processes. . Develops the right skills to meet the future needs of the organization. . Performs or assists with production support as needed. Required qualifications to be successful in this role: . GxP Quality Control / Analytical Development and/or Contract Research Organization laboratory operations experience . Excellent oral and written communication and interpersonal skills . Highly organized . Ability to analyze, articulate and solve problems . Ability to learn quickly, move with agility between assignments, multi-task, and to work effectively in a team environment, both face-to-face and remotely Preferred: . Experience with LIMS and/or ELN applications . Experience executing any role within the SDLC (including author, tester, coordinator, or project manager) . Requirements development, engineering or management knowledge . Experience with enterprise requirements management / application lifecycle management tools DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED Skill Set Years of Experience Proficiency Level Life Sciences 4-8 Very Good Business Analyst 2-5 Very Good Project Lead 1-5 Good LIMs SME 1-5 Good Minimum Education Required: Bachelor's degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience #LI-CG1 #DICE Skills: Business Process Analysis Life Sciences Leadership What you can expect from us: Insights you can act on While technology is at the heart of our clients' digital transformation, we understand that people are at the heart of business success. When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees 'members' because they are CGI shareholders and owners and owners who enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today - one of the world's largest independent providers of IT and business consulting services. At CGI, we recognize the richness that diversity brings. We strive to create a work culture where all belong and collaborate with clients in building more inclusive communities. As an equal-opportunity employer, we want to empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist. Ready to become part of our success story Join CGI - where your ideas and actions make a difference. Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics. CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned . We make it easy to translate military experience and skills! Click to be directed to our site that is dedicated to veterans and transitioning service members. All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances. CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI's legal duty to furnish information.
Monster

Philippines
Permanent
Full-time