Quality Specialist - Validation

Summary:

Summary: Ensures current Good Manufacturing Practices (cGMP) and FDA/internal Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation.

Primary Responsibilities of role:

? Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation.
? Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required.
? Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
? Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
? Write test cases to validate critical control points, user requirements, and functional designs.
? Execute test cases as needed.
? Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use."
? Assists in analyzing validation data to ensure acceptance criteria are met.
? Assists in writing validation summaries.
? Ensure milestones and timelines are met on assigned projects.
? Prepares validation reports for distribution.
? Evaluates adequacy of corrective actions.
? Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
? Prepares validation equipment for use at the Donor Center and for evaluation upon return.
? Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service."
? Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes."
? Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes."
? Monitors and trends customer complaints and nonconformance related to equipment failures.

Knowledge, skills, and abilities:

Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
Excellent quantitative and analytical skills.
Excellent oral and written communication skills.
Strong critical thinking and problem solving skills.
Ability to identify errors and provide corrective action.
Ability to work with others in a team environment.
Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.

Education Requirements: Bachelor's degree

Occupational Demands: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.

Pay Rate Range: $25-40/hr depending on experience