Quality Assurance Specialist - On Site

Job description

POSITION TITLE

Quality Assurance Specialist

PAY RANGE

65k-$80k p/y (Depending on experience)

DEPARTMENT

Quality

REPORTS TO

Quality Director

WORK LOCATION

In Person (Deer Park, New York)

POSITION OBJECTIVE

The Quality Assurance Specialist is responsible for assuring company compliance with all Industry and Regulatory requirements to support both retail and e-commerce platforms.

RESPONSIBILITIES

• Responsible for maintaining the SOP program including issuance and control over files.
• Responsible for maintaining the Change Control program.
• Responsible for APR generation.
• Responsible for internal audits. Create reports which include evaluation of results, recommendations for improvement, and timely CAPA follow-ups.
• Responsible for vendor qualifications.
• Support and track the sourcing and onboarding of new products, suppliers, and customers.
• Assist with Validation protocol generation and execution.
• Assist with recalls and mock recalls.
• Conduct and track training, including company-wide QA training for cGMP and SOPs.
• Assist with on-site regulatory and customer inspections.
• Suggest efficiencies while maintaining both quality and financial acumen.
• Assist with training QA staff.
• Assist with ordering materials, as needed.
• Maintain current computer database and files.

REQUIREMENTS

• 3+ years QA Experience
• Bachelor's degree preferred
• Experience in the Pharmaceutical, food, biotech, or cosmetic manufacturing industries preferred
• Solid knowledge of FDA cGMP regulations
• Self-directed and able to work well independently, as well as in a team environment
• Ability to work efficiently in a fast-paced environment.
• Proficiency with computer and Microsoft Office (Outlook, Word, Excel)
• Knowledge of Oracle or other similar system.
• Excellent reasoning, problem-solving, and writing skills
• Excellent communication skills; ability to effectively articulate quality-related issues to all levels of personnel

BENEFITS

• Paid Time off
• Paid Holidays
• 401(k)
• Medical Insurance
• Dental insurance
• Vision insurance

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the daily work environment is usually moderate and can change during the business day.

Job Type:

Full-time Pay:

$65,000.00 - $80,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person