Clinical Quality Assurance Auditor Jobs in Maine

Working knowledge of Microsoft Word required, Excel desired.

Problem solving, basic exchange of information, and interpersonal relation skills required.

CGMP and pharmaceutical manufacturing knowledge required, specifically an ability to recognize deficiencies in product quality and report to the appropriate supervisor(s).

Ability to tactfully manage conflict and influence outcomes required. Ability to fulfill a leadership or controlling role on end results desired.

This position pays $26.15 to $35.37 per hour, depending on experience, with opportunity for growth, promotion and annual raises.

Process final container samples; perform inspection and sampling according to SOP, Protocol, or client request memo.

Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines

Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.

Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution

Perform additional GCP related activities upon request by CQA management

Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.

Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.

Develop lessons learned and trends from on BPSQA audits. Promotes knowledge management.

Proven abilities to promote shared responsibilities across teams

Demonstrates ability to share knowledge and expertise with managers to support managers development

Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.

Advanced knowledge in strategic supplier quality oversight

Experience must include successful development and implementation of a clinical or pharmacovigilance audit program