Provides broad expertise to the department in one or more specialized areas, such as computer system audits, investigations, root cause analysis, batch record review, Total Quality Management (TQM), or other specialized areas/processes in the execution of the Quality Management System (QMS), which may include the performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise. May serve as client coordinator for company contracted services for large/significant programs and contribute to policy-making decisions as a resource in area(s) of expertise.
Serves as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g. reviews computer system validation data, lab investigations, root cause analysis, batch record review or total Quality Management.
Represents the departiment in client and regulatory inspections/audits, and leads in development, lifecycle tracking, and effectiveness measurement of corrective actions.
Participates in inter-departmental meetings and contributes to policy-making decisions.
Provides training for department and/or laboratory staff.
Evaluates acceptability of data based on criteria set forth in SOPs and methods.
Reviews data sample result tables and analytical reports for completeness and accuracy of data.
Utilizing department checklists, evaluates content of reports and compliance with reporting criteria.
Verifies accuracy of analytical results and sample identification, and inventories and submits data to archives.
Reviews complex batch records and associated documentation for completeness and accuracy of data.
May lead risk assessments.
Manages set up and filing of documents.
May mentor junior team members in area(s) of expertise.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills and Abilities:
Strong expertise in one or more specialized areas relevant to QA activities, e.g. computer systems, root cause analysis, TQM, batch record review, vendor management, CAPA, risk assessment
For laboratory positions, may require knowledge of chromatography, immunochemistry or statistics
Thorough knowledge of GMP and appropriate regional regulations and guidelines
Demonstrated proficiency in leading a range of project based or internal GMP audits and vendor audits
Excellent oral and written communication skills
Strong problem solving, risk assessment and impact analysis abilities
Solid experience in root cause analysis and CAPA management
Strong negotiation and conflict management skills
Ability to remain flexible and prioritize competing demands/work load
No management responsibility
Working Conditions and Environment:
Work is performed in an office, laboratory and/or GMP Depot environment.
For laboratory positions, potential exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.
Variable work hours to accommodate schedules
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of up to 50 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.
Regular and consistent attendance.