Haemonetics Work Values

Daily Duties at Haemonetics:

• Responsible for supervising Chemistry Laboratory and ensuring that all lab practices and procedures comply with current GMPs, GLPs, safety requirements and other applicable standards including but not limited to ISO, Health Canada, EU regulations. • Perform analytical activities employing traditional analytical methods for raw materials as well as finished products containing anticoagulant & additive solutions, using compendia wet chemistry methods as well as using state of the art instrumentation such as Ion Chromatograph and HPLC. • Develop, perform and validate stability indicating assays of sterile products. • Manage stability test protocols and perform associated analytical testing. • Assist in development of product specifications, raw material specifications, testing to support IND/NDA and 510K submissions and study protocols all with appropriate laboratory documentation. • Responsible for supervising and guiding Chemists to perform analytical development of new formulations and related assay methodologies, initiating NCMRs and CAPAs. • Responsible for analytical methods validation of existing and new solution products using HPLC, UV-VIS and IC techniques. • Perform and supervise analytical testing of raw materials, in-process and finished products. • Responsible for Stability Study program and subsequent testing of dry and wet set products. • Responsible for evaluation of trend analysis for water for injection and chemical assay testing and provide guidance for any corrective and / or preventive actions if necessary as per regulations. • Assist Quality Assurance department in CAPA investigation and subsequent documentation, FDA audits as well as internal & external audits. • Assist Q.A. incoming for revising raw material purchase specifications and also assist in Supplier audits. • Identifies needs for analytical instrumentation and assists with procurement and training.

What they like about Haemonetics:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Analytical method development, Method validation and method transfer, Technical writing skills writing validation protocols and reports, Proficient in writing stability study and engineering study protocols and reports, Experienced with CAPAs, NCMRs, Change Control, Docuemnt Control

Skills

Analytical method development, Method Validation and Method Transfer, Technical writing , Scientific writing, Writing validation, engineering, stability study protocols and reports, Hands on working and troubleshooting on IC, HPLC, GC-MS, LC-MS, UV-VIS

These are some of the questions we asked our climbers about their experiences with Haemonetics: