Regulatory Affairs Associate

1 month ago

Layton, United States Somafina Full time
Job DescriptionJob Description

Position Description:

The Regulatory Affairs Associate is a vital member of the Quality team; responsible for ensuring that pre- and post- manufacture documentation meet industry requirements and established specifications.

Essential responsibilities:

• Reviews Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) before and after production to ensure completeness and accuracy.

• Verifies documentation of production processes in accordance with current GMPs.

• Reviews product labels and proofs for regulatory and compliance with FDA, TGA and other regulatory bodies.

• Performs duties in accordance with standard operating procedures. • Verifies and audits compliance with standard operating procedures.

• Maintains training matrixes and audits employee training records to ensure effective employee training.

• Other duties as necessary.

Additional Responsibilities:

• Support of company, department, and/or safety procedures, programs and activities.

• Work well with other departments to facilitate improvements and timely deliverables.

• Develop and maintain team-oriented processes to achieve company objectives.

• Maintain a clean and orderly work area. • Other duties as assigned.

Education Requirements:

• High School diploma or equivalent required – Associate Degree preferred.

Competencies/skill Qualifications:

• Must demonstrate exceptional written and communication skills

• Ability to follow instructions / directions.

• Ability to work well under pressure in a fast-paced environment.

• Excellent attention to detail.

• Ability to prioritize and complete assigned tasks effectively and efficiently.

• Able to make decisions based on company guidelines.

• Exceptional organizational, multi-tasking and time-management skills.

• Ability to adapt to a dynamic environment and maintain effectiveness.

• Demonstrate integrity and willingness to take personal responsibility for performance.

• Proficiency with Microsoft Office Suite programs (Excel).

• Strong mathematics skills required.

• English proficiency required.

• Knowledge of Dietary Supplement GMPs preferred.

• Knowledge of good documentation practices (GDP) preferred.

• Experience in dietary supplement industry preferred.

• Auditing and regulatory label review experience preferred.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; converse and listen; taste or smell.

• Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects.

• Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

• May be exposed to a dusty environment and/or considerable noise.

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