Software Quality Assurance Director jobs in New Jersey

Packaging Manufacturer of Cosmetics is seeking a Quality Assurance Validation Specialist to join their team. This position is primarily responsible for reviewing and overseeing the validations executions for testing, equipment, batch processes, facility and cleaning of cosmetic & OTC manufacture and production.

The Quality Assurance Validation Specialist will be responsible for:

· Reviews and approves validation master plans, validation protocols, validation reports, validation deviations, SOP’S and other validation documentation in support of product release.

· Reviews and coordinates with Tech Service team the validation plan, schedule and organize new & existing validation projects including laboratory equipment, water systems, manufacturing and filling equipment, manufacturing and filling processes, plant systems, storage facilities and cleansing & sanitization processes.

· Managing the validations execution with the appropriate departments and personnel and, to provide them with the correct training of the validation protocol requirements.

· Provides technical input on validation deviations, proposes site-specific validation procedures and shared practices as applicable.

· Coordinates with Tech Service team the qualification IQ/OQ/PQ activities with manufacture, production, sanitization, quality control and outside testing facilities providing leadership, guidance and training.

· Reviews and approves protocols for validation/qualification IQ/OQ, PQ of existing processes, methods and equipment according to approved protocols and SOPs.

· Reviews the validation documents to analyze data, adjust where needed to confirm that a manufacturing or production process has consistent results and meets regulatory standards.

· Troubleshooting / investigating validation-related deviations.

· Maintaining organization and archival of completed validation and qualification document packages.

· Work with Tech Service team, manufacturing and Production to generate Failure Mode & Effects Analysis (FMEA) and risk assessments of new projects.

Job Requirements

· 3 years relevant experience in validation / batch processing role (regulated Cosmetic or Pharmaceutical industry)

· Familiar with validation discipline and processes.

· Familiar with CAPAs, Change Controls, OTC, FDA audits & investigations.

· Adept at Microsoft Office suite.

· Positive attitude, to adapt to fast changes, work under a lot of pressure, teamwork and have initiative. Bilingual is a plus.

For immediate consideration, please send resume outlining your related validation experience.

No relocation offered.

About the Assurance group

Securing top talent for our clients has been a passion for our each of our recruiters who have been representing the Assurance group for over 20 years. We work with some of the best companies in every industry….they are essential, entrepreneurial and enthusiastic about the future. Our tenure has given us the tremendous advantage to maintain relationships with both our clients and candidates

#IND2

Job Type: Full-time

Pay: $65,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Experience level:

• 3 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Work Location: In person