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SalaryThe incumbent in this classification will perform duties throughout the facility within the Biotechnology field. The Quality Assurance Reviewer / Document Control classification is a critical role for Kimera Labs Inc. to produce at scale in accordance with FDA, AATB, and ISO manufacturing standards, and while undergoing IND/clinical trials. The duties of this classification are performed in a biotechnology/science field.
The following are the Roles and Responsibilities of EMPLOYEE included but not limited to:
- Direct report to the QA Technical Manager under the Chief Regulatory Officer (CRO)
- Responsible for Reviewing, Assembling Executed Batch Records.
- Working close with the operators to address Batch Record errors in a timely fashion.
- Oversees the Employees training records, and training matrix. Keep up to date appropriate completion of all employees training documentation.
- Prepare the new employee introductory and on-going quality related training, as needed, and as required.
- Responsible for all training activities including introductory training to new hired employees.
- Responsible for Metrics, Exception documents such as Non-conformances, Deviations, OOS, Customer complaints, etc.
- Follow Investigation and CAPA procedures to monitor and trend investigation’s data.
- Responsible for keeping up to date all activities related to OSHA compliance.
- Responsible for overseeing the biowaste and hazardous material disposal.
- Oversee that Document Controls functions in keeping all the company records in order and up to date.
- Responsible for maintaining all regulatory documents such as SOPs, licenses and certificates; responsible for ensuring all equipment is validated and calibrations are kept current in Doc Control.
- Responsible for releasing the clean rooms for manufacturing operations.
- Assisting in Internal and External Audits from the regulatory agencies.
- Review Environmental Monitoring Data, Cleaning Forms, Logbooks, etc.
- Responsible for releasing from Material Management all necessary items for the use in manufacturing and Quality Control operations.
- Reviews SOPs, Investigational Reports, and other controlled documents as assigned.
- Observe processes and ensure compliance with all applicable state, federal and company-designated requirements.
- Handles any issues related to manufacturing performance, process, and safety to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
- Assist in data review of the quality control data of in process, FBP and FVP Quality Control data.
- Assist in the data review of Stability studies.
- Ensure that the final product observes the company's quality standards and implements corrective actions when necessary.
- Ability to use logic and reasoning to identify the strengths and weaknesses related the day-to-day work activities.
- Possess excellent oral and written communication skills to effectively interact with executives, management, and staff.
- Perform other duties as assigned by management.
Note: This list of duties is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities or qualifications that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Minimum Qualifications Required:
- Bachelor’s degree in science or related field is required.
- Master’s degree in science or related field is preferred.
- Minimum 5-10 years of experience in medical manufacturing environment or relevant field.
- Experience in cGMP environment is a plus.
Job Type: Full-time
Pay: $60,000.00 - $75,000.00 per hour
Expected hours: 40 – 45 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
