- Review Production Batch Records and Quality Control Reports for finished product release.
- Review QC reports for purified water testing, stability testing, and other records generated in QC lab.
- Review & Perform QA investigations for: Nonconformance and Recalls, CAPA's, Complaint, OOS.
- Trains Laboratory Technicians.
- Review and audit production operations, warehouse and QC lab for GMP compliance.
- Review or/and write SOP's, WI's, and Forms, if needed.
- Verify the optimal performance of the actual Quality System and implements procedures to improve the company Quality System.
- Verify that compounding processes (liquids and semi-solids) are being followed according to the batch records.
- Ensures that bulk products in quarantine areas are kept clean, organized, and with limited access to compounding personnel only.
- Verify logbooks, forms, and other documents that must be reviewed in Compounding (liquids and semi-solids) areas.
- Implement and oversee QMS system with other QA members.
- Assay method
- Assay validated (protocol and results)
- Approve Master Production Records
- Review and approve batch records before release for production and after production
- Review analytical testing
- Review product development testing
- Release batch records for further processing or shipment
- Review/ approve batch record documentation (CoA's, outside testing, etc)
- Review QA investigations
- Nonconformance Recalls
- CAPA's
- Complaints
- Label review & approval
- Review and audit production for GMP compliance
- Supports by reviewing and completing batch record documentation.
- Assist QA/QC Director in revision and investigations of: Nonconformance products, CAPA's, Complaints, Annual Product Revision.
- Assist QA/QC Director oversee work of production and compounding supervisors.
- Assist QA/QC Director with revision and audit production, QC and logistics operation for GMP compliance.
- Attend weekly supervisors' meetings, take minutes to report to management, and create projects/tasks in QMS as needed.
- Assist in audits with regulatory agencies such as the FDA and third-party auditors.
- 3 plus years
- Bilingual English/Spanish preferred
- Familiarity with quality standards and processes to follow federal, state, and local regulations
- Communication skills to convey information in reports, meetings, and status reports
- Knowledge of the product to perform accurate quality control
- Attention to detail
- Analysis, critical thinking, and problem-solving skills to review systems, find flaws and pose solutions to those flaws
- Ability to handle stress
- Ability to operate under deadlines while still meeting standards
- Excellent organizational and time-management skills
- Clear and accurate data entry and documentation skills; strong follow-through and perseverance to handle multiple tasks simultaneously
- Strong competency working with integrated data systems, Microsoft Office Suite, including Outlook and intermediate to advanced Word and Excel (i.e., spreadsheets, formulas, importing and exporting of files, as applicable) as required
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Quality Assurance - Mineral Wells, United States - OHM PHARMA INC
3 weeks ago
Description
Job DescriptionJob Description
Principal responsibilities include:
Collect information for outside testing including:
Qualifications required for the position:
Job Type:
Full-time, Monday through Friday, day shift
Pay:
According to experience
Benefits:
Health Insurance
Dental Insurance
Vision insurance
Life insurance
Company Description FDA-registered OTC natural homeopathic pharmaceutical manufacturer located in Mineral Wells, Texas.
Family-owned and operated.
24 years of manufacturing high-quality herbal and homeopathic medicines under FDA guidelines.
Company Description
FDA-registered OTC natural homeopathic pharmaceutical manufacturer located in Mineral Wells, Texas.\\rFamily-owned and operated.\r24 years of manufacturing high-quality herbal and homeopathic medicines under FDA guidelines.
