THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

MAJOR DUTIES AND RESPONSIBILITIES:

· Assigns/supervises daily duties to all levels of IPQA Inspectors

· Provides training to all IPQA inspectors and all production personnel on product quality and acceptability

· Performs final batch record review and release as needed

· Performs finished product inspections when required

· Verifies pre and post clearance activities during production runs.

· Performs monitoring and verification of monthly logbooks (temperature, pressure differential, equipment logs, etc.)

· Performs incoming inspection and release of packaging components when required

· Performs issuance of labels to production floor when required

· Acts as a liaison between Quality and Production.

· Performs Quality Investigations in congestion with Operations and Maintenance team

· Supervise and maintain quality inspection activities performed by all IPQA inspectors including but not limited to finished product inspections, component inspections and raw material inspections.

· Ensures inspection activities meet FDA and ISO requirements, as well as implements continuous improvements daily

· Performs quality monitoring of quality and production inspection activities.

· Demonstrates/trains and promotes GDP and cGMP practices to all personnel on the production floor

· Provides support to all other departments in an overall quality capacity when needed (lab, warehouse, etc.)

· Promote teamwork and customer satisfaction.

· Participate in other activities as assigned by the Quality Management Team

QUALIFICATION:

· Working knowledge of FDA regulations for drugs and/or medical devices

· Knowledge of inspecting critical parameters for following products: aerosols, tubes, liquids

· Minimum of 5 years’ experience in a related position within Quality Assurance Department is required

· High School diploma or equivalent

CRITICAL SKILLS AND ABILITIES:

· Working knowledge of FDA regulations for drugs and/or medical devices.

· Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.

· Ability to make quality decisions and act accordingly.

· Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

· Ability to perform effectively under conditions of fluctuating workload.

· Ability to handle and resolve recurring problems.

· Communicate with others clearly and concisely.

· Ability to work in a fast-paced environment – sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.

· Strong initiative, technical commitment and contribution to company and departmental goals