What are the responsibilities and job description for the Validation Compliance Specialist position at CONFLUX SYSTEMS?
Experienced Quality Assurance Professional Opportunity in Pharmaceutical Industry
Location: Ridgefield Park, NJ 07660
Duration: 12-18 Months with possible extension ON-SITE
Position Description
Key Responsibilities:
Employment Type: Contractor
Location: Ridgefield Park, NJ 07660
Duration: 12-18 Months with possible extension ON-SITE
Position Description
Key Responsibilities:
- Assist in the development, review, and approval of various cGMP documents such as Master Validation Plans, FAT/SAT documents, SOP's, and more.
- Provide expertise and solutions related to CQV Lifecycle documentation in compliance with FDA/EMEA Regulations.
- Support validation activities for projects by reviewing validation documentation and attending validation activities.
- Offer QA support to uphold CQV guidelines for equipment, analytical equipment, utilities, and facilities.
- Collaborate with cross-functional teams including Manufacturing, Validation, Quality Control, and others.
- Ensure thorough investigation and resolution of validation discrepancies and errors.
- Undertake additional duties across departments as requested by the QA Manager.
- Bachelor's degree in pharmaceutical sciences, engineering, chemistry, or related field.
- 5-7 years of experience in validation, biological quality assurance, or quality control within FDA-regulated biotechnology or pharmaceutical companies.
- Strong knowledge of cGMP regulations and familiarity with other relevant standards.
- Proficiency in risk assessments and risk-based approaches.
- Excellent project management and collaboration skills.
- Strong written and verbal communication skills.
- Customer-focused with exceptional problem-solving abilities.
- Prioritization and time management skills.
- Detail-oriented with the ability to work accurately in a fast-paced environment.
- Self-motivated and proactive with excellent IT skills.
Employment Type: Contractor
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