Quality Assurance

Job Purpose:

The Quality Assurance will oversee and direct the quality system and QA program. He/she will coordinate programs and projects related to quality and review laboratory practices 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 establish corporate strategic 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 a quality improvement system that will help grow the business by focusing on customer satisfaction, cost efficiency and continuous process improvements.

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

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

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

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

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

· Direct 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 company-wide effective training on the QMS, cGMP and others 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 in a scientific discipline (preferably chemistry) plus at least 10 years’ industry experience.

· QA certifications (e.g. CQA) preferred.

· Ability to successfully develop, communicate and execute a strategic quality vision.

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

· Attention to detail, and understanding of analytical skills and laboratory techniques.

· Strong organizational and multi-tasking skills to achieve high quality lab work and meet deadlines.

· Knowledge of FDA, DEA, GMP, and USP is required.

· Good communications skills (written and oral) and solid critical thinking skills.

· Current Good Manufacturing Practice experience required.

· Knowledge of Microsoft Excel and Word

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Norcross, GA 30093: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location