Validation Specialist - Quality Systems

Totowa, NJ

Full Time

Mid Level

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
PTO

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Validation Specialist - Quality Systems

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