Quality Assurance Training

2 weeks ago


Los Angeles, United States PureTek Corporation Full time

**ESSENTIAL RESPONSIBILITIES**:

- **Maintain and manage PureTek training program**
- Publish the annual training calendar and distribute it to department managers.
- Coordinate training sessions with all departments.
- Maintain training matrix and track training compliance status of all department
- Ensures all corrective and preventive actions are documented and implemented.
- Ensures all staff comply with the Company’s SOPs, cGMPs and regulatory guidelines.
- Maintains all Quality Systems logs and tracks on time completion.
- Processes Questionable Material Reports (QMR), Material Destruction Records (MDR), Deviations, and Reprocessing Orders (RO) as needed. Collects monthly reports from the Quality Unit.
- Manage the complaints program, documentation, and responses.
- Updates SOPs and assists with other QA related documents.
- Maintains appropriate QA records and documentation.
- Maintain list of Allergens, Organics, Active Pharmaceutical Ingredients (APIs) Raw Materials.
- Assists in preparation and distribution of management reports and other documentation related to areas of responsibility.
- Audit fire extinguisher, eyewash and shower stations inspection reports.
- Audit PureTek facilities for safety compliance with state/federal safety regulations.
- Adheres to company policies and procedures and sets a positive example for others within the organization.
- Establishes priorities to ensure timely job completion.
- Assist in all Regulatory audits both internal and external.
- Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors and outside agencies.
- Complete all other additional tasks assigned by supervisor/management.

**QUALIFICATIONS**

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Discretion in handling confidential and sensitive matters.
- Knowledge of drug cGMPs, SOPs and regulatory guidelines including FDA requirements.
- Knowledge of QA industry best practices.

**EDUCATION & EXPERIENCE**
- Bachelor’s degree in Science (chemistry, pharmacy, or biology) or equivalent work experience.
- One to two years Quality Assurance related experience in a cGMP Drug/ device manufacturing environment.

**TECHNICAL SKILLS**
- Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint.
- Ability to quickly learn new software programs as needed



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