Alumni Affairs Director jobs in Gastonia, NC

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.

• Responsible for Coordination of the following: Selection of Finished Product Lots for Placement in the Stability Program/Overseeing Inventory and Storage of Stability Studies/Pulling Samples for Stability and Forwarding samples to Laboratories for Testing/Removing Samples of Completed Studies from Inventory: Work with Manager to create an Annual Stability Requirements Matrix. Monitor production schedules and coordinate with Packaging to select lots for stability and ensure placement of such lots in the stability program. Ensure Monthly stability schedules are generated and communicated to Laboratory and Support Staff. Work with Stability Associates to ensure samples are pulled and delivered to the Laboratories at scheduled due dates and that study samples are discarded upon completion of studies.
• Responsible for Building Studies in ScienTek and Maintenance of Executed Stability Protocols: Ensure new studies are created in ScienTek Stability System Software. Work with Stability Associates for stability data entry in ScienTek and coordinate Quality Affairs Review and Approval of Stability data entry to create Stability Reports. Provide approved Stability Reports to Support Functions as required.
• Responsible for Maintaining Inventory of Finished Product Retain Samples: Communicate quantity of finished product retain samples required. Work with Stability Associates to Ensure Collection, Inspection, and Inventory Control of finished product retain samples.
• Oversee Operation of Stability Equipment: Work with Manager and Stability Associates in coordination with the Maintenance Department and stability equipment vendors to ensure preventative maintenance and calibrations are scheduled and performed on stability equipment as required. Assist with investigation of equipment excursions.Ensure routine Monitoring of Temperature and Humidity of Stability Storage Areas/Chambers is performed and that reports are generated and reviewed from the AmegaView Monitoring System. Respond to AmegaView alarms, as required. Ensure Mappings of Stability Storage Areas/Chambers stability areas are performed as required and that Overall Annual Reviews of all Stability Storage Areas/Chambers storage areas are performed as required.
• Customer Complaint Assistance: Work with Quality Affairs Specialists on Customer Complaints Investigations when required. Serve as back-up to Manager for Complaint Approvals, as required.
• Annual Product Review generation: Work with Quality Affairs Specialists on generation of Annual Product Reviews when required. Serve as back-up to Manager for Annual Product Review Approvals, as required.
• Participate in Internal Audits to assess compliance to GMPs.
• Participate in Regulatory Field Actions: Participate in Field Actions such Recalls, Field Alerts, etc. as required.
• Other Duties as assigned by Manager.

• BA/BS in Chemistry/Biology/related science or Comparable Post Secondary Schooling with applicable industry experience
• At least 5 years industry experience with knowledge of Pharmaceutical Systems.

• Strong problem solving and investigative skills.
• Excellent oral and written communicative skills.
• Understanding of Regulatory Codes
• Good interpersonal skills
• Computer Literacy

• Microsoft Software
• ScienTek Software
• AmegaView Software

• No PPE's Required
• Ability to occasionally lift up to 50 pounds.
• Ability to withstand short periods at elevated temperatures (hot/cold)

Equal Opportunity Employment

Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.