The Laboratory Technician will play a crucial role in maintaining and updating Master Batch Record documentation, ensuring accurate product release, and resolving quality issues.
Responsibilities
Assist in maintaining and updating Master Batch Record documentation, including new, revised, and obsolete records.
Review Production Batch Record documentation to ensure accurate product release.
Assist with investigations to identify and resolve quality issues.
Ensure adherence to company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
Conduct routine audits of production processes, perform quality reviews of documentation and production processes to ensure compliance with cGMP standards.
Qualifications
Bachelor's Degree in Biological Science, Chemistry, Biomedical Engineering, or a related field or Associates/High School Diploma with relevant work experience.
Required Skills
Ability to work with chemicals used in compound preparation while following all required safety protocols.
Ability to wear required personal protective equipment.
Strong understanding of basic principles, policies, and procedures related to compounding.
Preferred Skills
Experience in a pharmaceutical/cosmetic manufacturing environment or a similar role.
Familiarity with GxP, FDA, ICH, and OSHA requirements.
Proficient in Minitab, Excel, and other relevant software applications.