Position Summary:
The ideal candidate will be responsible for ensuring that all products meet the required standards of quality, safety, and efficacy. This role plays a critical part in our commitment to delivering high-quality OTC products to our customers. Responsible for ensuring accuracy of receiving, shipping, and inventory controls.
Responsibilities:
Quality:
- Review lab results for conformance
- Communicate with lab on reports
- Perform and submit environmental monitoring to lab- quarterly and yearly with Quality.
- Weekly water sampling
- Air monitoring
- Development of documents, procedures, and schematics.
- review of All incoming material. (All documentation and shipments received- COA, SDS, Specs, etc)
- Request of Supplier Documentation if needed.
- Quality and regulatory support in External Audits, as needed.
- Complete and close batch record to include yield and reconciliation.
- Help RD/QA development with review of raw materials for new customers.
- Review of inventory date codes for all raw materials for testing.
Procurement:
- Communicate with current supplier(s) on material specifications and expectations.
- Manage active material sourcing and cost-saving opportunities with supplies.
- Submitting PO of raw materials as needed for production orders.
- Submitting purchases for 80% of JRF supplies.
Warehouse shipping and receiving, Storage and Inventory:
- Managing and organization raw materials to Finish Good inventories.
- Review and cycling materials with team.
- Constant overview of all materials used- Packaging, JRF Supplies, raw materials
- Receive and validate incoming materials with Andrea.
- Verify client’s final product: Quality of product, Quantity produced, laboratory results, shipping details, and final invoicing.
- Handle and manage Domestic, international, and third-party shipping.
- Understanding of all materials received.
- Maintain label inventory to include: reconciliation, verification, and proofing w/ suppliers.
Operations:
- Forecasting with inventory use and future planning for production.
- Creating Standard Operating Procedures for inventory controls and warehouse operations.
Finance:
- Support Finance with shipping and final invoicing.
- Assisting in operation supply cost, expense and usage.
Requirements:
- Bachelor's degree in Microbiology, Chemistry or Biology. Preferred.
- Minimum of 2 years of experience working in a quality control role within the OTC manufacturing industry.
- An understanding of cGMP regulations and FDA guidelines pertaining to OTC products.
- Experience with laboratory instrumentation and equipment.
- Excellent attention to detail and accuracy in documentation.
- Effective communication skills, both verbal and written, with the ability to collaborate across departments.
- Proven problem-solving abilities and the capacity to work independently as well as part of a team.
- Familiarity with quality management systems (QMS)
- Ability to adapt to changing priorities and work in a fast-paced environment while maintaining a high level of professionalism and quality.
- Experience with process validation, Equipment qualification and cleaning validation.
- Must be able to lift up to 60 lbs.
- Minimum 2 years experience of inventory management.
Preferred Qualifications:
- Bachelor's degree in a relevant scientific discipline.
- Previous experience with method development and validation.
- Knowledge of statistical analysis software for data interpretation.
- Experience with automated inventory management software.