Quality Assurance Specialist

Job Summary:

As a QA Specialist, you will be responsible for managing all documentation related to quality

assurance, including the issuance and review of batch records, Corrective and Preventive Actions

(CAPAs), deviations, and Standard Operating Procedures (SOPs). You will also oversee

customer-related documentation such as Certificates of Analysis (CoA), Formula Product

Specifications, and Letters of Guarantee. Additionally, your role includes maintaining document

control, supporting training efforts, and assisting in audits to confirm compliance with regulatory

standards.

Key Responsibilities:

• Issue and review batch records to ensure completeness, accuracy, and compliance with regulatory requirements.
• Review and approve documentation related to manufacturing processes, including work orders, labels, and specifications.
• Issue finished product labels and packaging artwork to production to ensure proper labeling and packaging of products.
• Maintain document control systems, ensuring all quality-related paperwork is properly filed and accessible.
• Oversee the implementation and tracking of Corrective and Preventive Actions (CAPAs) to address quality issues.
• Investigate and manage deviations from established processes and ensure proper documentation of corrective actions.
• Assist in the creation, revision, and review of Standard Operating Procedures (SOPs) related to quality assurance and compliance.
• Ensure that batch records and related documents comply with Good Manufacturing Practices (GMP) and company policies.
• Manage customer-related documentation, including Certificates of Analysis (CoA), Formula
• Product Specifications, and Letters of Guarantee.
• Provide training and guidance to employees on documentation procedures, CAPAs, deviations, SOPs, and other quality assurance practices.
• Coordinate with various departments to ensure timely and accurate completion of documentation.
• Assist in internal and external audits, ensuring documentation meets required standards.
• Monitor document revisions and ensure proper version control for all quality documents.
• Conduct regular reviews to ensure that the documentation process is efficient and compliant.
• Support continuous improvement initiatives related to documentation processes and quality systems.
• Perform other duties as assigned by management.

Qualifications:

• High school diploma or equivalent required.
• Proficient in English (reading, writing, and speaking).
• Previous experience in quality assurance or documentation control, preferably in a manufacturing environment.
• Familiarity with GMP, CAPAs, deviations, customer documentation (CoA, Formula Product Specifications, Letters of Guarantee), and regulatory requirements.
• Strong attention to detail and organizational skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and manage multiple tasks simultaneously.
• Strong communication skills (both written and verbal).
• Ability to work effectively in a team environment.

Additional Skills:

• Strong communication skills for effective reporting.
• High problem-solving ability in fast-paced environments.
• Flexibility to adapt to dynamic operational needs.
• Computing skills (Word, Excel, PowerPoint) to generate reports and maintain records.

Equal Opportunity Employer Statement:

GummyWorks is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all

employees.