Quality Assurance Specialist

Job Overview
We are seeking a dedicated and detail-oriented Quality Assurance Specialist to join our team. The ideal candidate will be responsible for ensuring that our products meet the highest quality standards and comply with industry regulations. This role involves conducting quality inspections, managing quality systems, and performing audits to maintain compliance with FDA regulations, and other relevant standards.

Responsibilities

• Support in a quality perspective the cGMP manufacturing and packaging operations at the site, including dispensing, mixing, filtration, filling, visual inspection, and packaging.
• Support in a quality perspective the microbiology and chemistry laboratory operations at the site.
• Support in a quality perspective the warehousing operations at the site.
• Support in a quality perspective the engineering / facility operations at the site.
• Support in a quality perspective the research and development operations at the site.
• Support incoming inspection – including sampling, in-process inspection, and finished product inspection.
• Perform and support process validation, cleaning validation, and routine validations – such as mappings, media fill simulation studies, VPHP studies, and load pattern studies.
• Perform and support monitoring and or reviewing environmental systems (Temperature, Relative Humidity, and Air Pressure Differential) where and when applicable.
• Support in a quality perspective the commissioning of cGMP equipment and instruments including the review / execution of qualification protocols (Installation Qualification, Operation Qualification, and Performance Qualification).
• Perform calibration tasks that include but are not limited to balances, scales, and temperature / humidity sensors.
• Monitor the preventive maintenance program.
• Execute the review of executed documents such as but not limited to manufacturing studies, microbiology studies, and chemistry studies.
• Prepare quality reports for the cGMP commercial products and cGMP operations, including but not limited to annual product reviews, quarterly water systems, environmental systems, and microbiology systems reports.
• Prepare and revise cGMP documents such as but not limited to process validation protocols, cleaning validation protocols, Effective Official Lists, and SOP’s.
• Execute the review and approval process of creation and revision of batch records to ensure proper cGMP manufacturing steps and guidelines are being followed.
• Attends training scheduled in every new or revised SOP related to the department’s function.
• Assures accomplishment of training program.
• Attends cGMP courses and seminars scheduled by the company or by an outside contractor.
• Provides excellent service and ensures customer satisfaction eliminating any kind of complaints from internal and external customers.
• Generates and implements improvements related to area functions.

Skills

• Bachelor's degree in Engineering or Chemistry or equivalent.
• Strong understanding of FDA regulations and cGMP standards.
• Experience in conducting quality audits and implementing corrective actions.
• Knowledge of manufacturing processes and quality inspection techniques.
• Excellent analysis skills with the ability to interpret data effectively.
• Familiarity with QA/QC methodologies and quality systems management.
• Experience using vision inspection systems for product evaluation.
• Strong attention to detail and commitment to maintaining high-quality standards. Join us in our mission to deliver exceptional products while ensuring compliance with industry standards. Your expertise will play a crucial role in maintaining our reputation for quality excellence.

Job Types: Full-time, Permanent

Pay: From $50,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $50,000