Quality Assurance Specialist Jobs in USA Formulations LLC North Brunswick, NJ

Job Title: Quality Assurance Specialist

Location: North Brunswick, NJ

Role Overview: Quality Assurance Specialist will manage the creation, organization, distribution, and maintenance of our company's compliance documents. This role is essential in ensuring alignment with SOPs, Good Manufacturing Practices (GMP), and 21 CFR Part 211 requirements.

Areas of Responsibility:

o          Prepare and manage customer product specification documents, Certificates of Analysis (COAs), Safety Data Sheets (SDS), and vendor qualification documentation.

o          Review and approve product labels and supplement facts to ensure accuracy and regulatory compliance.

o          Coordinate the preparation, storage, and retrieval of Standard Operating Procedures (SOPs) and regulated documents.

o          Maintain training records, document retention, and manage sample archives.

o          Prepare and approve technical questionnaires and other quality-related documents.

o          Review and release finished products in compliance with quality standards.

o          Conduct and document investigations and address customer complaints effectively.

o          Review and file stability protocols, stability reports, and annual product reviews.

o          Create, review, and distribute documentation that meets regulatory standards for end-users.

o          Monitor regulatory requirements related to documentation, implementing updates as needed.

o          Work closely with internal teams to understand and document processes and regulatory requirements.

o          Participate actively in the Company’s quality management team and assist with process improvement initiatives.

o          Apply for necessary licenses and permits for company operations.

o          Comply with all safety and job-related training requirements.

o          Perform additional tasks as assigned.

Skills & Abilities:

•           Excellent written communication skills, particularly in English.

•           Proficient in Microsoft Excel, Word, Outlook, and possess accurate typing skills.

•           Ability to interact professionally with various department heads.

•           Capable of managing multiple tasks efficiently and maintaining confidentiality with a high level of ethics and integrity.

•           A positive and professional attitude with strong organizational skills.

Educational Requirements:

•           BS Degree in a relevant field preferred.

•           Minimum of 4 years of technical experience or an equivalent combination of education and experience.

Physical Requirements:

•           Ability to sit, stand, and walk as required, with occasional lifting up to 30 lbs.

•           Frequent use of hands for typing and handling documentation.

Work Environment:

•           Primarily an office-based role with temperature-controlled settings; occasional work in warehouse or manufacturing areas with appropriate PPE (safety shoes, hair nets, face masks, gloves, or disposable jumpsuits) as required.