Operations Quality Manager

Position Summary:

The OQM will provide leadership and direction to the daily operations of Hydrox manufacturing, packaging, and shipping.

RESPONSIBILITIES:

• Provides leadership, direction, and work hands-on in performing Quality functions including Incoming Inspection & Release, In-Process QA, Label Control, and Material Disposition.

• Monitors day-to-day manufacturing activities to assure production processes are in compliance with and followed as per the FDA guidelines, written standard operating procedures and company policies

• Supervisory oversight of the operations Quality group, namely inspectors and quality technicians.

• Advises other operations and production departments about quality assurance issues that affect their realm of responsibility.

• Documentation review and approval for the Operations Quality.

• Performs data analysis investigation of trends for root cause analysis, creating corrective/preventive actions, and ensuring effectiveness of the actions for products.

• Creates standard operating procedures to ensure quality assurance compliance with current good manufacturing practices.

• Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.

• Immediately communicate to management any issues or problems potentially impacting product, processes and/or any activities for the organization.

• Interface with other departments to ensure information is communicated to these department heads concerning quality matters in a timely and complete fashion.

• Participates in audits conducted by regulatory agencies and consultants.

Education, Abilities and Skills:

• B.S. / B.A. in Science related discipline with experience in a pharmaceutical/cosmetics manufacturing organization highly preferred, other regulated industries may be acceptable.

• Thorough understanding of FDA cGMP regulations and experience in handling Regulatory inspections.

• Knowledge of pharmaceutical formulation and manufacturing processes.

• Minimum of 3years of supervisory or management experience in pharmaceutical/cosmetics quality assurance.

• Must have proven interpersonal skills, and be able to direct the activities of subordinates.

• Able to perform statistical analysis in developing test levels and in performing investigations. Knowledge of Six Sigma Green Belt and lean tools preferred.

• Excellent problem solving aptitude, communication and multi-tasking skills.

• Excellent verbal and written communication skills.

Pay: $100,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Vision insurance

People with a criminal record are encouraged to apply

Experience:

• Management: 3 years (Required)
• FDA regulations: 3 years (Preferred)
• Quality assurance: 3 years (Preferred)

Work Location: In person

Salary : $100,000 - $120,000