Government, Regulatory and Code, Pharmaceutical, Quality, Quality Engineering
Plan, conduct, and report assigned quality assurance audits. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Provide quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Q2 Solutions functions.
Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Q2 Solutions contracts to assess compliance with applicable regulations/guidelines, customer requirements, Q2 Solutions SOPs and project specific guidelines/instructions.
Conduct quality assurance activities and projects for clients according to Q2 Solutions departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.
Assist in preparation and review of corrective action plans.
Represent quality assurance program on customer and project teams under the direction of more senior QA staff.
Document and report quality and compliance issues to QA management according to required timelines.
Advise quality assurance management on system audit needs.
Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management.
Assist in preparation and review of corrective action plans associated with customer audits
Enhance and maintain a working knowledge of relevant GXP regulations
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of word-processing, spreadsheet, and database applications.
Considerable knowledge of GXP regulations and quality assurance auditing techniques.
Strong interpersonal skills.
Excellent problem solving skills.
Effective organization, communication, and team orientation skills.
Ability to initiate assigned tasks and to work independently.
Ability to manage multiple projects.
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
3 years experience in pharmaceutical, technical, or related area including GCP and/or Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
Additional Salary Information: Base compensation plus bonus; medical, dental, vision, 401k, employer paid life insurance, and many other benefits are offered.
Internal Number: R1057067
About Q2 Solutions
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.