Quality Specialist
BelcanDurham, NC, United States14 hours ago
Job type
- Full-time
Job descriptionEnsures current Good Manufacturing Practices (cGMP) and 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 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. Bachelor's degree 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.
Job Title : Validation Quality Specialist
Pay Rate : $35 / hr
Duration : 3 Months
Location : Durham, NC
Area Code : 919, 984
ZIP Code : 27709
Start Date : Right Away
Keywords : #QualitySpecialist #Biomedical
Benefits :
- Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision
- 401k
- On the job training / cross-training
- Life Insurance, disability insurance
- Voluntary life insurance for family members available.
- Accident and critical illness insurance optional.
- Scheduled performance reviews
- Referral program
Responsibilities :
Requirements :
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Quality Specialist • Durham, NC, United States
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