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Quality Assurance Specialist

4 months ago

Rosenberg, United States OCUSOFT INC Full time

**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.

*
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**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.

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- **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.
- Ability to work in a fast-paced environment and meet relevant deadlines.
- Ability to adapt to changes in schedules and priorities.
- Ability to independently or collaboratively as part of a team.

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

Application Question(s):

- Are you experienced in working with raw materials, food or pharmaceuticals?

Ability to Relocate:

- Rosenberg, TX 77471: Relocate before starting work (required)

Work Location: In person