QA & Regulatory Coordinator

City of Lincoln; Town of Smithtown (NY); On-site; USD 52,000 - 53,000; Full time

Job summary

Bio-Botanica® is a family-owned company specializing in botanical extracts for cosmetics, dietary supplements, food, and beverages. The QA and Regulatory Coordinator will manage supplier qualification, material evaluation, and regulatory documentation, ensuring cGMP compliance and proper batch review.

Under the QA and Regulatory Manager, responsibilities include deviation investigations, SOP adherence, and cross-functional collaboration with Operations, Purchasing, Sales, and Quality to maintain

Qualifications

• Bachelor’s degree in science/biology/chemistry/pharmacology or related field.
• Minimum one year regulatory/quality assurance experience.
• Good interpersonal and communication skills; English (verbal & written).
• Proficient in MS Word and MS Excel; ability to learn new software.

Responsibilities

• Coordinate all new supplier, raw material qualification and approval activities.
• Perform QA line clearance and in-process monitoring for production areas including pharmacy, extraction, distillation, blending, capsules, tablets, liquids, and materials handling.
• Oversee the review and approval of all production batch documentation before, during, and after batch manufacture.
• Ensure all batch documentation is properly completed, including usage, cleaning, and monitoring logbooks.
• Develop and establish material specifications and master data (Allergen, Kosher, Halal, Non-GMO).
• Review material testing data and monitor for compliance; perform final dispositions and releases.

Skills

Interpersonal communication

English communication

MS Word

MS Excel

Organized, detail-oriented

Education

Bachelor’s in science/biology/chemistry/pharmacology or related field

Tools

MS Word

MS Excel

Job description

• Base Pay $52,000.00 - $53,000.00 / Year
• Job Category Manufacturing & Production
• Industry Pharmaceutical, Dietary Supplement, Food Manufacturing and Formulation
• Employee Type Exempt
• Required Degree 4 Year Degree
• Manage Others No

Contact information

• Email [e-mail]

Description

Bio-Botanica® is a family-owned and operated company specializing in botanical extracts for over 50 years. We are a leading manufacturer of 500+ quality botanical extracts for cosmetic, dietary supplement, food, and beverage industries. A well-recognized industry innovator known for pioneering numerous advancements in the botanical field, we pride ourselves on long-term customer relationships developed since 1972, based on both flexibility and versatility in manufacturing products tailored to a broad range of applications. In addition to our B2B services, our branded products, led by our flagship Nature’s Answer® brand, are carried in retail stores throughout the U.S. and internationally.

Under the direction of the QA and Regulatory Manager, the QA and Regulatory Coordinator is responsible for all aspects of quality and regulatory surrounding purchased and manufactured raw materials, bulk products, and finished products. This includes supplier qualification, raw material evaluation and approval, specification development, material testing review and disposition, quality and regulatory documentation development and maintenance, batch record review, and deviation/investigation management. They are the key resource for Operations, Purchasing, Sales, Marketing, Quality, and Regulatory on all raw material, bulk product, and finished product related issues. They are also responsible for adherence to and enforcement of Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs).

Requirements

• Coordinate all new supplier, raw material qualification and approval activities. Ensure all materials are properly evaluated and that only approved suppliers and materials are purchased.
• Perform QA line clearance and in-process monitoring for production, packaging, and warehouse areas such as pharmacy, extraction, distillation, blending, capsules, tablets, liquid products, materials handling, and other daily QA floor activities.
• Oversee the review and approval all production batch documentation before, during, and after batch manufacture.
• Ensure all associated batch documentation is properly completed, including usage, cleaning, and monitoring logbooks.
• Develop and establish appropriate material specifications for all raw materials, bulk products, and finished products. Ensure these specifications are accurate, maintained, and current.
• Develop and establish appropriate master data (i.e Allergen, Kosher, Halal, Non-GMO) for all materials. Ensure this master data is accurate and maintained.
• Review material testing data and monitor for compliance. Perform final material dispositions and releases.
• Coordinate with Purchasing and vendors when non-conformances surrounding incoming materials arise. Conduct proper investigation and appropriate disposition.
• Ensure all required documentation is on file and readily available for all materials, including interacting with suppliers to procure their documentation and developing new internal documentation that is accurate and aligned with regulations.
• Participate in deviations, investigations, non-conformances and reworks
• Identify and report any material quality / GMP issues with products/personnelnot meeting specifications/policies to supervisor.
• Perform other duties as assigned.
• Comply with company policies and procedures and maintain regular work attendance.
• Follow SOPs, cGMP, Quality, Safety Rules, and Food Safety and Food Defense practices.

Education / Experience / Training/ Skill:

• Bachelor’s in science/biology/chemistry/pharmacology, or a related field is required.
• Minimum one year previous regulatory/quality assurance experience
• Good interpersonal and communication skills. Must be able to communicate in English (verbal & written).
• Good computer skills, including proficiency in MS word, MS excel. Ability to learn new software.
• Can produce high-quality documentation of work and work in a fast-paced environment.
• Organized, systems oriented with a special attention to detail.