Quality Specialist Validation

Durham, NC - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Specialist - Validation

Location: 79 TW Alexander Dr Bldg. 4201 Durham NC 27713

Duration: 12 Months (Possible extension for a longer duration)

Work Schedule: Mon-Fri from 8:30 AM to 4:30 PM

Job Description:

Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation review and approval of validation and quality assurance/control documentation
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 before 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 the adequacy of corrective actions.
Participates in the evaluation of processes systems and individual center equipment needs and the 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:

Bachelors 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 F* and high levels of noise in production areas.
Exposure to electrical office and laboratory equipment.
Personal protective equipment is required such as protective eyewear garments and gloves.
Frequently sits for 4-6 hours per day. May stand bend and twist 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 are 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.

Job Requirements:

High School Diploma or equivalent. One year of laboratory experience is preferred.
Proficient in Microsoft Office and Google Suite experience with SAP or equivalent ERP system is a plus.
Prior experience with shipping / receiving is a plus.
Must exhibit professionalism and ability to serve as a greeter and escort for site vendors for deliveries and services.
Capable of multi-tasking and following standard operating procedures.
Ability to lift to 50 pounds & operate a pallet jack.

Job Title: Quality Specialist - Validation Location: 79 TW Alexander Dr Bldg. 4201 Durham NC 27713 Duration: 12 Months (Possible extension for a longer duration) Work Schedule: Mon-Fri from 8:30 AM to 4:30 PM Job Description: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols...