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Quva · 8 hours ago

Quality Systems Senior Specialist - Corporate

United States

Full-time

Hybrid

Senior Level

6+ years exp

Quva is an industry-leading health-system pharmacy services provider, and they are seeking a Quality Systems Senior Specialist to manage and coordinate Quality Management Systems. This role involves leading data collection, overseeing audits, and ensuring compliance with quality standards to guarantee the safety and efficacy of medications.

Health CareManufacturingMedicalMedical DevicePharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead collection of data to support APR, Management Review, Quality Management Maturity, Quality Metrics, CAPAs, and Investigation trends

Using the systems above, monitor key performance indicators (KPI) which identify Quality risks allowing CAPAs to be implemented preventing a catastrophic event occurring

Leads and/or provides oversight and support with Agency or Large Customer Inspections/Audits at each of the Quva sites. May include the coordination and assistance with document retrieval during audits and inspections

Interact with other departments to coordinate QMS activities and collection and/or analysis of data

Manage and maintain the COR QMS with authority to resolve and/or escalate issues

Supports the Corporate Quality Systems Manager with the creation, revision, review, approval, and implementation of procedures supporting the previously listed QMS aspects

Assists Corporate Quality Systems Manager in developing, establishing communication, and meeting strategies supporting the QMS, including an escalation process when Quality risks have been identified

Review applicable documents for compliance with company standards and create applicable GAP analysis as required

Coordinate roles and responsibilities providing assignment of QMS activities to ensure completion on time

Lead and participate in process improvements and projects within the company

Provides mentorship to Corporate Quality Systems Specialist(s) and Site Quality Systems personnel when needed

Qualification

Quality Management SystemsFDA regulationsCAPA managementData analysisMicrosoft OfficeProject managementVerbal communicationWritten communicationAttention to detail

Required

Bachelor's Degree in life science and/or a minimum of six (6) years equivalent work experience

Experienced in FDA-regulated pharmaceutical or 503B Sterile Compounding Industry (cGMP processes)

18+ years of age

Able to successfully complete a drug and background check

Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Understanding in updating Standard Operating Procedure, with documentation of summary of changes and version control

Ability to manage projects coordinating cross-departmental activities

Proficient in Microsoft Office, Adobe, Word, and Excel

Detail-oriented with strong verbal and written communications skills

Benefits

Comprehensive health and wellness benefits including medical, dental and vision

401k retirement program with company match

17 paid days off plus 8 paid holidays per year

Company

Quva

Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.

Founded in 2015

Sugar Land, Texas, USA

1001-5000 employees