Lannett Company, Inc . is a rapidly-growing leader in the manufacture of generic pharmaceuticals. We are seeking a highly talented and self-motivated professional with experienc e in to join our team as a Quality Assurance Manager . The position requires someone with supervisory or management experience in Quality Assurance in a pharmaceutical manufacturing organization.
The QA Manager will be responsible for overseeing the entire product life cycle from raw materials to manufacture, packaging and shipping to ensure that cGMP requirements and SOPs are being appropriately followed. The position is responsible for the systems, data, and professional staff required to implement a comprehensive quality assurance program that meets current and future needs.
The successful candidate must have a Bachelors degree in chemistry, biochemistry, or a related field from a four-year college or university. A minimum of 7 years of work experience in pharmaceutical working with packaging or manufacturing operations is required with at least 3-5 years of supervisory and management experience. Must possess good verbal and written communication skills, attention to detail, and the ability to prioritize and organize multiple tasks simultaneously. Must be proficient in MS Word, Excel and Outlook. Must have strong mathematical skills, good cGMP knowledge, and proven technical writing ability.
- Ensure that all packaging materials, raw materials, labeling, and both in-process and finished goods meet SOP and cGMP requirements at all times.
- Development and maintenance of sampling plans within all operations, and the reviewing and auditing of all data obtained during all quality assurance activities to ensure consistency and compliance.
- Maintain Quality Systems such as CAPA and Inspection Readiness Plan.
- Identify trends and issues and keeping management both informed and involved and initiating activities and actions to improve the situation.
- Maintain a working knowledge of FDA Guidance’s and code of federal regulations. Assist in FDA audits
- Supervise, direct, develop, and train a professional staff to successfully perform all QA operations and duties while achieving company, department, and personal objectives.
- Investigate customer complaints regarding quality (non-medical complaints).
- Maintain legal retain programs for packaging materials, raw materials and finished goods.
- Review and approve labeling and labeling revisions for finished product.
- Review and final approval of validation documents (protocol, summary reports), manufacturing and laboratory investigation reports, change controls, SOP’s and other controlled documents.
We offer a comprehensive benefits package, including medical, vision, dental, prescription, immediate eligibility in the 401(k) plan with company match, Employee Stock Purchase Plan, and tuition reimbursement.
Please include your salary requirements in order to be considered. Candidates must possess authorization to work permanently in the United States. Seeking local candidates from the Philadelphia area only – no relocation provided. Successful candidate must be able to pass a company paid background check and a drug test.
Lannett Company Inc. - 2 years ago
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