Formulated Solutions Innovates, Formulates and Creates consumer brands. We put together a broadly talented team of experts in manufacturing, production, laboratory, regulatory, distribution and marketing, that possesses an unparalleled drive to deliver market-ready products of the highest quality. Our in-house technologies in Aerosol, Biochemistry, Cosmetic, Pharmaceutical and Polymer Chemistry, coupled with innovative package design and strategic marketing services, provides clients with one of the fastest design-to-market solutions in the world. We serve companies in pharmaceutical, cosmetic, personal care and specialty chemical applications. We also support small and large companies in generating and producing unique products for the retail market.

Formulated Solutions offers a wide range of benefit options for our full-time employees, allowing them to find the right plan to enroll into. We also offer 401k with a company match and much more! If you are hard-working, self-motivated and looking for a new and exciting career opportunity, apply today!

PRIMARY PURPOSE:

Seeking Quality Specialist with appropriate knowledge and skills based on cGMP, CFR, ISO, and/or FDA experience. The Quality Specialist will support Quality Management in establishment and implementation of quality system in accordance with cGMP; FDA, and international regulation.

MAJOR DUTIES AND RESPONSIBILITIES

• Knowledge of Quality Assurance/Control methods, principles, and practices based on cGMP, CFR, ISO, and/or FDA recommendations.
• Knowledge of the relationship of Quality Assurance to other activities such as production, engineering, purchasing, and/or warehouse activities.
• Perform review of batch records prior to lot/batch release.
• Prepare and complete batch record processing for final release
• Skill in written and oral communications and in establishing effective interpersonal relationships.
• Follow all safety and cGMP procedures.
• Keep all documents organized and accessible.
• Promote continuous improvement and customer satisfaction.
• Perform other duties as assigned by Quality Management.

QUALIFICATION:

A. Required

• Experience working in a Quality Assurance and/or Quality Compliance role.
• Ability to follow detailed procedures/SOP and maintaining accurate records is required.
• Experience in an FDA-regulated industry (i.e. pharmaceutical/medical device).
• Knowledge of FDA and cGMP manufacturing guidelines.

CRITICAL SKILLS AND ABILITIES:

• Ability to maintain detailed and accurate records.
• Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and compile reports (i.e. Microsoft Office).
• Strong math and strong analytical skills.
• Self-motivated and self driven towards results.
• Communicate with others clearly and concisely.
• Ability to work in a fast-paced environment-sometimes with rapidly shifting priorities.
• Ability to focus priorities and concentrate in a regulated environment.

EDUCATION AND/OR TRAINING

• High School Diploma or equivalent.
• Junior College or Technical School graduate or post-High School education/certification is highly desirable.