Quality Assurance Manager
Position requires a detail-oriented individual who is responsible for ensuring that the drugs manufactured at Washington Homeopathic Products meet prescribed quality levels. As such, the following duties are performed:
Implements quality control programs; prepares quality guidelines for production and quality control of pharmaceuticals.
Conducts quarterly audits of processes for conformance to cGMP and to detect deficiencies; recommends corrective action. Conducts quarterly/annual review of products.
Administratively supervises quality unit staff by setting performance standards, approving or disapproving leave, and taking or recommending disciplinary action according to company policy.
Keeps records of quality reports, statistical reviews and relevant documentation. Facilitates proactive solutions by collecting and analyzing quality data.
Audits and/or certifies vendors and suppliers of WHP components. Validates Certificates of Analysis per WHP procedures.
Serves as primary contact during FDA on-site inspections of facility as well as follow-up.
Stays abreast of internal policies and external rules and regulations. Prepares and updates quality documentation, basing processes on 21 CFR Parts 210 and 211.
Working with the WHP Production Manager, ensures that employees working in production are aware of quality requirements. Provides training in best practices. Promotes a culture of quality within the organization.
Reviews statistical data from the production lines to identify quality problems. Analyzes data and recommend changes to production processes or quality controls.
Performs investigations of customer complaints and product or process deviations. Analyzes records to identify specific problems or trends over time. Develops and monitors continuous improvement programs, aiming to reduce the number of defects and improve levels of quality.
Develops and conducts validations for processes, cleaning, and equipment. Oversees change control program.
Performs final release of finished product assuring that documentation is complete and accurate.
Position is located in Berkeley Springs, WV.
Full-time position (40 hours per week), Monday through Friday.
A bachelor's degree from an accredited institution in Chemistry, Pharmaceutical Science, Quality Management, or a related field of study
A minimum of three (3) years of related QA/QC experience in a pharmaceutical cGMP environment, as well as supervisory and team leadership experience, including both hourly and salaried employees
Working knowledge of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing and validations
Relevant understanding and knowledge of 21 CFR Parts 210 and 211 regulations
- Quality assurance auditing and effective regulatory communication skills