Technical Consultant

4 weeks ago


Lexington, Kentucky, United States Apolis Full time
Job Summary:

The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions - Quality, Validation and Product Development. This role requires a strong understanding of software application implementations in GxP environments and experience with project upgrades from Win 7 to Win 10. The ideal candidate will have excellent written and verbal communication skills and be able to work in a controlled environment requiring special gowning.

Key Responsibilities:

Collaborate with business and IT teams to provide project support for MA Biologics Operations Site Functions - Quality, Validation and Product Development.
Manage project upgrades from Win 7 to Win 10.
Provide oversight of vendor-provided solutions.
Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned.
Work with other Direct team members for decisions, and clarifications as needed.
Must be able to juggle multiple projects and deliverables, and split billing time between projects where needed.
Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc.
Must poses GXP experience with lab equipment.

Requirements:

More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements.
Experience with software application implementations in GxP environment.
Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration.
Experience in the Pharmaceuticals or Life Sciences industry.
Experience consulting or working in a complex, global matrix organization.
Knowledge of Lean operational techniques.

Physical Demands:

Must be able to lift, push, pull and carry up to 30 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment:

Must be able to work in controlled environments requiring special gowning. Will potentially be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tabaco, candy etc. may be used in the QC / Manufacturing environment.
During onboarding and training Onsite requirement will be 5 days per week.
Afterwards minimum 3-4 days a week onsite is required.
Must be able to work overtime as required.
May be required to work in a confined area
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