CGI Technologies and Solutions, Inc. Lab Operations Analyst in Plymouth Meeting, Pennsylvania
Lab Operations Analyst
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Lab Operations Analyst
Category: Business Analysis (functional and technical)
City: Plymouth Meeting, Pennsylvania, United States
Position ID: J1020-2042
Employment Type: Full Time
Meet our professionals
CGI: A company committed to clients
The Lab Operations Analyst will specifically be a member of QC Lab Analyst team in preparing the laboratories of manufacturing and research site for converting processes, analyses, and master data to a new Labware LIMs.
Your future duties and responsibilities:
RESPONSIBILITIES WILL INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:
• Provides subject-matter expertise and support to QC Lab Analyst teams as needed in the following areas:
• Take direction and work within a team.
• Develop close working relationship with Laboratory SMEs and management
• Familiar with GMP lab processes and data capture with knowledge of regulatory considerations
• Provide Business analysis current and future state mapping.
• Operate in Pharmaceutical QC Labs include Environmental Monitoring, Microbial, Bioburden, Virology, Sterility, Stability, Analytical, etc.
• Demonstrates facility in client-facing activities including:
Eliciting and documenting business requirements.
Analyzing and validating 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.
Identifies and resolves requirements gaps by working with both Business and IT to ideate functional and non-functional solutions
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:
SKILLS / KNOWLEDGE REQUIRED
• Expertise in QC testing, laboratory process, and experience within a pharmaceutical GMP compliant analytical lab
• Laboratories Information Management Systems, desirable
o Labware LIMS Master Data usage, development, and changes.
o SQL*LIMS Master Data usage, development, and changes.
• Excellent communication and interpersonal skills.
• Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture
• Strong organizational skills, able to make good decisions in a collaborative manner
• Bachelor’s degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience
• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance 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
• Ability to support internal and external projects from inception to successful implementation
• Familiarity with software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management
• Exceptional verbal and written communication skills; expertise in setting and managing customer expectations
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management
• Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence
• Strong customer focus and ability to manage Client expectations
Skill Set Years of Experience Proficiency Level
Business Analyst 1-5 High
GxP Experience 1-5 High
LIMs SME 1-5 All Levels
Laboratory SME 1-5 All Levels
- Business Analysis
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, 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 USEmploymentCompliance@cgi.com . 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 .
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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 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.