Team Lead - QA Testing & Validation
Primary Duties & Responsibilities:
- Responsible for identifying adequate level of Quality Assurance oversight on various IT and computerized systems.
- Oversee and develop time and cost estimates to ensure forecasted QA estimated are in sync with the anticipated project deadline and budget
- Review & provide input, where required, to the 21CFR11/Annex 11 Validation Requirement Decision Tree as submitted to QA for all new Projects.
- Assign QA resources for all testing and validation activities.
- Coordinate and provide direct oversight of third-party vendors/partners for software testing and/or software validation activities.
- Coordinate with the appropriate IT teams and/or third party vendors to ensure software meets or exceeds specified standards and end user requirements.
- Review and obtain appropriate project artifacts from project team and ensure adequacy to resume QA testing.
- Oversee and assist in the development of various QA artifacts such as test plan, test cases, risk assessment, defect log, test summary, etc. Provide walk through to relevant stakeholders as required.
- Oversee and participate in various test activities including functional, integration regression and smoke tests in accordance with Innomar’s established testing procedures.
- Review and approve various RFC documentation ensuring completeness of appropriate documentation for validated and non-validated systems
- Provides oversight, review and approve artifacts provided by third party vendors (as assigned per project)
- Supports specialized testing as needed including security testing, environment readiness, batch schedule validation, performance and automated testing
- Conducts QA audits throughout project life cycle. These activities include review of design documents through review of testing results and associated defect records.
- Participate in the creation and maintenance of documentation to support processes and/or applications.
- Responsible for ensuring completeness and adherence to Standard Operating Procedures (SOP) and provides guidance on creation of those SOPs.
- Coordinate with IT, QA and applicable business unit management in the training on testing policies, practices and tools to project team members. This may consist of informal activities such as on-on-one training up through formal preparation of training materials and classroom training.
- Facilitates User Acceptance Testing activities
- Provides coaching and advice on best practices surrounding Quality Assurance initiatives and acts as an ambassador of Quality.
- Complies with all appropriate policies, procedures and safety rules and regulations.
- Travels up to 15% of the time.
- Performs related duties as assigned.
- May be required to be on standby/on call as part of this role.
What your background should look like
- Requires a minimum of seven (7) years in validation of GxP systems as well as software development methodologies
- At least five (5) years as a Quality Assurance Analyst in a large enterprise environment with extensive integration activity and interactions with external vendors
- Experience with centralized, distributed, and desktop applications.
- Familiar with documentation tools.
Minimium Skills, Knowledge, and Abilities Required:
- Bachelor degree in information systems or related field
- Minimum 5 years’ experience working as a QA Analyst, preferably with healthcare software applications
- Experience working in an Agile environment
- Experience using JIRA and Confluence and MS Office tools including Visio
- Experience with Healthcare message standards is a plus
- Proven innovative leadership skills in the area of software testing and validation.
- Experience in validation of GxP systems is required.
- Experience in auditing of IT and validated systems is required.
- Experience in creation and review of Standard Operating Procedures (SOP) is required.
- Ability to use automated enterprise testing tools to support and assist company testing initiatives.
- Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
- Excellent teamwork and interpersonal skills.
- Excellent leadership and relationship building skills.
- Ability to communicate effectively both orally and in writing.
- Strong analytical, problem-solving and conceptual skills.
- Excellent organizational skills; attention to detail.
- Ability to resolve system issues effectively and efficiently.
- Ability to prioritize workload and consistently meet deadlines
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.
This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.