Associates degree and at least 2 years of experience in GMP pharmaceutical manufacturing, research and development, or pharmaceutical equipment manufacturing.
Experience working in a GMP or regulated manufacturing environment with a strong understanding of compliance and quality expectations.
Hands-on experience with batch records and Good Documentation Practices (GDP), including batch record review and accurate documentation of manufacturing activities.
At least 2 years of experience in batch record review, quality assurance operations, and line clearance activities.
Pharmaceutical or contract development and manufacturing organization (CDMO) GMP experience in production or chemical manufacturing involving equipment operation and SOP-driven processes.
Knowledge of current Good Manufacturing Practices (cGMP) and familiarity with pharmaceutical manufacturing processes.
Experience as a manufacturing operator or packaging technician in a regulated environment.
Ability to read and interpret SOPs, manuals, batch records, work instructions, and specifications.
Basic mathematical skills, including addition, subtraction, fractions, percentages, ratios, and proportions, and the ability to apply these concepts to practical manufacturing tasks.
Proficiency with computer applications for data entry, word processing, and email communication.
Ability to perform repetitive tasks while maintaining high levels of accuracy, speed, and attention to detail.
Familiarity with pharmaceutical manufacturing equipment and processes, including room and equipment setup, operation, and cleaning.
Experience working around quality assurance and compliance requirements, including exposure to investigational and quality systems activities.
Demonstrated ability to successfully complete regulatory and job-specific training requirements.
Comfort working within IT platforms to enter and manage production data and documentation.
Strong attention to safety, including consistent use of personal protective equipment and adherence to engineering controls.