Quality Assurance Specialist

Jove Laboratories manufactures liquid bulk products on-site to support the filling of towelette sachets, liquid bottles, and product packaging in many different formats.

With an on-site quality lab, Jove Laboratories operates with clean spaces, along with environmental and engineering controls, to comply with FDA requirements for GMP production facilities.

Key Responsibilities

• Safety
• Uphold safety protocols and standards in all quality assurance activities.
• Report and address any safety concerns promptly.
• Conduct thorough inspections of incoming raw materials and components to ensure compliance with quality standards.
• Assess the quality and conformity of raw materials and components to release them for production use.
• Work closely with the procurement team to communicate any deviations or non-compliance issues.
• Document and maintain records related to the release of raw materials.
• Incoming Inspections
• Conduct thorough inspections of incoming raw materials and components to ensure compliance with quality standards.
• Assess the quality and conformity of raw materials and components to release them for production use.
• Work closely with the procurement team to communicate any deviations or non-compliance issues.
• Document and maintain records related to the release of raw materials.
• Batch Record Issuance
• Manage the issuance of batch records for production processes.
• Ensure that batch records are accurate, complete, and comply with GMP and QMS requirements.
• In Process Inspections
• Perform Line clearance for manufacturing and packaging activities.
• Perform inspections of in-process manufacturing and packaging to verify compliance with quality specifications.
• Provide feedback and support to stakeholders to address issues.
• Maintain records of in-process packaging inspections.
• Batch Record Review
• Conduct comprehensive reviews of batch records for accuracy and adherence to quality standards.
• Identify and communicate any deviations or non-conformities.
• Collaborate with manufacturing to resolve issues and ensure corrective actions are implemented.
• Release of Finished Product
• Evaluate finished goods to ensure they meet quality requirements before release.
• Work closely with distribution and logistics to coordinate the release of finished products.
• Document and maintain records of finished goods release activities.
• Equipment Calibration
• Review and verify the calibration records of equipment used in the quality assurance process.
• Coordinate with maintenance to address any calibration issues promptly.
• Communication
• Establish effective communication channels with the quality control and operations teams.
• Collaborate on addressing quality issues, implementing improvements, and ensuring continuous quality enhancement.
• Record Retention
• Maintain accurate and organized records, including training records, in accordance with regulatory requirements.
• Support audits by providing requested documentation promptly.
• Document Control
• Participate in document control processes, ensuring the accuracy and accessibility of quality-related documents.
• Execute document version control procedures
• QMS Compliance
• Comply with QMS requirements and Good Manufacturing Practices (GMP) throughout operations.
• Participate in internal and external audits as necessary.
• Physical Requirements
• Physical presence on site required to perform all duties.
• Ability to stand and walk for extended periods of time with or without reasonable accommodation.
• Mobility to work in typical office and field (warehouse/production) settings and use standard office equipment.
• Strength to lift and carry up to 25 pounds.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.
• Regularly wear a hairnet, bump cap and beard guard if necessary for the duration of your workday.
• Over the age of 18 and legally authorized to work in the United States.
• High school diploma required, bachelor’s degree in a relevant field preferred.
• Previous experience in a quality role is preferred.
• Strong organizational and time management skills
• Intermediate math skills.
• Excellent communication skills.
• Proficiency with MS Office applications required.
• Ability to independently or collaboratively as part of a team
• Ability to work in a fast-paced environment and meet relevant deadlines.
• Ability to adapt to changes in schedules and priorities.

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Holidays
• Monday to Friday
• Weekends as needed

Work Location: In person

Salary : $50,000 - $60,000