Title: Validation Specialist
Reports to: Quality Systems (QA) Manager / Supervisor
Department: Quality Assurance / Quality Control

Responsibilities:

• Create process validation/qualification draft protocols and reports for further review and approval by cross-functional teams and clients.
• File and maintain all validation records, including using of electronic modules (ERP) and files for documents retentions.
• Track process validation, qualification, and maintain associated reports.
• Initiate, Track, perform initial assessment of impact of changes to process validations and qualified processes.
• Review and Track and Submit Change Control Notices (CC) for changes as needed.
• Participates in internal and external audit process.
• Initiate failure investigations and deviations related to process validations and qualifications.
• Create validation design matrix to support GxP.
• Participates in product recall audits, internal audits, annual drug/device reviews.
• Monitor Process validation and line trials for OTC and Medical Device products.
• Maintain all OTC validation records in Quality Systems Library.
• Executed Validation checklist; support line trials; and support drug stability programs.
• Monitor and track Cleaning and Sanitization validations. Perform, obtain and coordinate swabbing activities and samples.
• Support IQOQ and Calibration process and tracking.
• Participate in Code Red projects, Gate Reviews and Validation Lifecycle programs.

Qualifications:

• Minimum of GED or equivalent.
• One to two years of industry or related experience.
• Excellent knowledge of Word, Excel, Power point
• Good technical writing skill and Good record-keeping skills.
• 5S & cGMP & exposure to contract manufacturing (previous training a plus).
• Ability to lift and carry up to 10-15 pounds.

Compensation & Benefits:

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match

• Create process validation/qualification draft protocols and reports for further review and approval by cross-functional teams and clients.
• File and maintain all validation records, including using of electronic modules (ERP) and files for documents retentions.
• Track process validation, qualification, and maintain associated reports.
• Initiate, Track, perform initial assessment of impact of changes to process validations and qualified processes.
• Review and Track and Submit Change Control Notices (CC) for changes as needed.
• Participates in internal and external audit process.
• Initiate failure investigations and deviations related to process validations and qualifications.
• Create validation design matrix to support GxP.
• Participates in product recall audits, internal audits, annual drug/device reviews.
• Monitor Process validation and line trials for OTC and Medical Device products.
• Maintain all OTC validation records in Quality Systems Library.
• Executed Validation checklist; support line trials; and support drug stability programs.
• Monitor and track Cleaning and Sanitization validations. Perform, obtain and coordinate swabbing activities and samples.
• Support IQOQ and Calibration process and tracking.
• Participate in Code Red projects, Gate Reviews and Validation Lifecycle programs