Lead Quality/GxP Auditor - Durham, United States - LS Solutions Inc

LS Solutions Inc Durham, United States

3 weeks ago

Pharmaceutical / Bio-tech

Description

Role: Lead Quality/GxP Auditor

Location: Durham, NC, Onsite)

Duration: 12 Months Contract

Job Description:

Identify, analyse, and determine solutions regarding capability gaps

Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities - then design an appropriate curriculum

Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/procedures

Facilitate the review of documents and training materials to ensure compliance and learning requirements are met

Requirements

B.S./B.A. in scientific discipline as a minimum

Minimum 3 years of GxP auditing experience in related industry

Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry

Experience working in a GxP (regulated) environment.

Experience in technical writing

Demonstrated program/project management skills

Experience with learning & development business processes

Demonstrated ability to establish strong business relationships

Demonstrated ability in communication, conflict resolution, and judgment and managing complexity

Working knowledge of business area/function

Experienced in Vendor management

Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business requirements

Ability to work independently and in a team environment.

Strong start-up mindset - think deliver execute review cycle

Strategic operator - think of where we need to go, but also the tactical ways to get there

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