Quality Assurance

The Quality Assurance associate will perform QA functions and oversee the quality system and QA program. He/she will approve Certificates of Analysis, coordinate quality functions and projects related to quality, and review cGMP documentation and procedures to ensure compliance with company procedures and regulatory requirements.

Major Responsibilities (include but not limited to):

· Participate with the senior leadership team to improve and maintain company quality plans and objectives in an effort to develop a robust and responsive Quality Management System (QMS).

· Ensure that all company personnel are trained and understand their responsibilities with respect to the QMS, company procedures, and regulatory requirements.

· Implement continuous quality improvement measures that will help grow the business by focusing on customer satisfaction, cost efficiency, and continuous process improvements.

· Identify related quality goals, objectives, and performance metrics that drive continuous improvement.

· Conduct regular reviews of quality assurance related metrics and corrective actions with the Leadership team .

· Conduct and manage third party and internal audit processes to assess procedural and industry compliance including GMP and FDA.

· Ensure the quality function demonstrates complete adherence to the company’s QMS.

· Oversee the investigation and reporting on quality assurance related issues to include root cause and corrective action identification and implementation monitoring.

· Oversee the preparation and maintenance of all quality related documentation to include but not limited to standard operating procedures (SOPs) in support of the QMS.

· Develop and manage delivery of effective company-wide training on the QMS, cGMP and other programs as required.

· Maintain the company’s central file system and record retention program.

· Perform all responsibilities in accordance with company guidelines, SOPs and protocols and appropriate industry, quality and regulatory standards, guidelines, rules and regulations.

· Follow all safety/regulatory/company procedures and guidelines in the conduct of work.

· Complete and maintain all training required and related to the duties of this position

· Perform other related duties as required.

Required Qualifications:

· BS preferably in Chemistry, or Microbiology plus at least 5 years experience in an FDA regulated industry.

· Ability to successfully communicate and execute quality directives.

· Excellent interpersonal, supervisory, verbal, and written communication skills.

· Strong organizational and multi-tasking skills.

· Knowledge of FDA, and GMP, is required.

· Current Good Manufacturing Practice experience required.

· Knowledge of Microsoft Excel and Word

Job Type: Full-time

Pay: $40,000.00 - $50,000.00 per year

Benefits:

• Paid time off

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Experience:

• cGMP: 5 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person

Salary : $40,000 - $50,000