Quality Assurance Specialist
OCUSOFT INC OCUSOFT INC Rosenberg, TX Rosenberg, TX Full-time Full-time $50,000 - $60,000 a year $50,000 - $60,000 a year 7 days ago 7 days ago 7 days ago Key responsibilities Safety Uphold safety protocols and standards in all quality assurance activities.
Report and address any safety concerns promptly.
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 work on weekends, holidays as well as off shift.
Ability to stand and walk for extended periods of time with or without a 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, safety glasses, bump cap, hearing protection and steel-toed shoes for the duration of your workday.
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 Experience level:
1 year 2 years Schedule:
8 hour shift Holidays Monday to Friday Weekends as needed Work setting:
In-person Manufacturing facility Office Warehouse Ability to Relocate:
Rosenberg, TX 77471:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Report and address any safety concerns promptly.
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 work on weekends, holidays as well as off shift.
Ability to stand and walk for extended periods of time with or without a 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, safety glasses, bump cap, hearing protection and steel-toed shoes for the duration of your workday.
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 Experience level:
1 year 2 years Schedule:
8 hour shift Holidays Monday to Friday Weekends as needed Work setting:
In-person Manufacturing facility Office Warehouse Ability to Relocate:
Rosenberg, TX 77471:
Relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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