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 internal 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.
Bachelor’s Degree in Scientific or related fields required
5+ years experience in biotech or pharmacuetical industry
Excellent verbal and written communication skills
Excellent organizational skills and attention to detail
Excellent time management skills
Strong analytical and problem-solving skills
About Washington Homeopathic Products
Washington Homeopathic Products has been in business since1873, and the company started as a homeopathic pharmacy in Washington, DC where it served the local communities, including the National Homeopathic Hospital. In the last 29 years, Washington Homeopathic Products has grown from a storefront pharmacy to one that is now serving more than 65,000 customers in more than 100 countries. Our clients include practitioners, MDs, DOs, NDs, midwives, veterinarians, pharmacies, retail stores, distributors, and the general public. All of this was accomplished under the leadership of Joe and Linda Lillard and resulted from their dedication to provide safe, effective and affordable medicines.