Overview
QA Engineer III Jobs in Billerica, MA at f5
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
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Title: QA Engineer III
Company: f5
Location: Billerica, MA
