Quality Assurance Auditor Job - Biotechnology: Southern Research Institute, Birmingham, USA

Τρίτη, Δεκεμβρίου 20, 2011

Αναζήτηση Θέματος

The Quality Assurance Auditor position requires demonstrated GLP/FDA experience within the Life Sciences industries (such as Biotechnology and Contract Research) - this is NOT a position within the scope of IT, Manufacturing, or Food. Please carefully review the description of the duties/qualifications before applying.

General Summary

This position is responsible for monitoring non-clinical laboratory studies and facilities at the Birmingham facility to assure management that applicable systems, facilities, records and controls are in compliance with appropriate regulations and standards. The incumbent prepares and maintains records of inspections/audits and reports findings to individual study directors and to management. The incumbent is involved with internal Study Directors, Department Directors, Managers and client / sponsor interactions and relationships to a significant level.

Key Responsibilities:

Inspects study functions and facilities for compliance with protocols, sponsor specifications, Standard Operating Procedures, and applicable regulatory requirements.
Reviews protocols for regulatory requirements. Reviews data and reports for accuracy, internal consistency, and compliance with protocol requirements, sponsor specifications, Standard Operating Procedures and applicable regulations.

Position Specific:

Assists in the implementation of Southern Research’s quality goals and objectives. This will include: participating in department meetings to disseminate QA and regulatory information as appropriate; maintaining quality assurance data files; conducting training and ensuring that the Master Schedule required by Good Laboratory Practice regulations is updated appropriately.
Participates in pre-study meetings to provide input on appropriate regulations and documentation concerns. Schedules inspections/data audits/report reviews for assigned work. Reports quality assurance findings to appropriate personnel verbally as needed, and in writing. Makes recommendations for corrective action.
Interacts with sponsors and regulators. Performs follow-up on sponsor/regulatory concerns resulting from those reviews, as appropriate.
Adapts systems, procedures, and data forms to expedite and improve quality assurance methods and record keeping for Birmingham.
Provides quality assurance consultant information on computer system/ subsystem and equipment validation efforts.
Conducts audits of subcontractors, vendors, or others providing support of regulated work.
Performs other duties as may be required by supervisor.
Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) regulation or standard requirements, and study protocols.

Requirements/Minimum Qualifications:

BS in relevant discipline and 4 - 6 years related experience. Or, HS Diploma with 8 - 10 years of related experience.
Quality assurance/quality management experience desired.
Demonstrates competence of internal auditing practices.
Demonstrates ability to provide basic resolution to a range of problems.

Work Environment & Conditions

This position is in a combination office and laboratory environment and requires (at times) the use of personal protective equipment (PPE) including:

Safety glasses
Respirator (varies based on tasks and barrier requirements)
Tyvek/scrub suits
Nitrile and latex gloves (varies based on tasks)
Hearing protection (varies based on tasks)
Shoe covers
This physical requirements of the position include:
Standing, walking, or sitting for extended periods of time
Be able to work in confined spaces.
Individuals who will enter BSL-2/BSL-3 labs must: satisfactorily meet medical requirements; obtain required vaccinations; pass and maintain in depth security and background checks, including, but not limited to, clearance to handle select agents; wear required PPE; and have effective communication skills. All offers of employment (and continued employment) are subject to drug testing.

Core Behaviors

Customer Focus: Makes customers and their needs a primary focus of one's actions; developing and sustaining productive customer relations.
Contributes to Team Success: Actively participates as a member of a team to move the team toward the completion of goals.
Builds Trust: Interacting with others in a way that gives them confidence in one's intentions and those of the organization.
Results Achievement: Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
Safety Awareness: Identifies and corrects conditions that affect employee safety; upholds safety standards.

Position: Project Manager