Packaging Coordinator-3rd Shift

Description

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.

Basic Purpose

Provide administrative and technical support to the Packaging Operations.

Essential Functions and Responsibilities

• Perform Packaging department related QAD (inventory management system) transactions.
• Maintain and organize production records.
• Review production records for bulk accountability / reconciliation and errors.   
• Perform accurate QAD and inventory transactions.
• Review all in-process and completed records for accuracy and completeness; resolve errors within department. 
• Comply with plant safety policies.
• Practice, promote, and adhere to cGMP’s at all times.
• Stay current on new/revised SOP’s.
• Assist Supervisors with coordination of weekly/monthly departmental SOP training and ensure that training is completed on time.
• Maintain the appearance of the work area in a clean and sanitary condition.
• Comply with all company rules, policies, etc.
• Complete issuance of department production records on time to avoid changeover delays.
• Assist Packaging Supervisor with the allocation and reallocation of Packaging Operators to different Packaging Lines during the shift.
• Maintain attendance controllers and vacation logs in the event that the Supervisor is absent.
• Maintain control of department SOP’s/SOF’s and assist with review of SOP’s/ SOF’s annually.
• Support shift operations at all times and especially when Supervisor is absent.
• Audit packaging lines for correct SOF revisions
• Initiate Do Not Ship Authorizations, In-Process Test Procedure, Sampling Form, Sampling and Inspection Plans, and Change Controls
• Attend daily production meeting and distribute an updated production sheet to the Packaging Lines daily.
• Perform Month End Inventory duties.
• Other duties as assigned by Supervisor.

Knowledge, Skills, Qualifications and Physical Requirements

The following describes the general knowledge, skills, qualifications and physical requirements normally associated with performing the essential functions of this job.  In compliance with law Cosette Pharmaceuticals will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

Education/Training/Work Experience

• High school diploma or equivalent
• Previous pharmaceutical or chemical manufacturing experience is desirable
• Thorough knowledge of QAD is preferred

Specialized Knowledge and Skills

• Good PC skills with knowledge of Windows-based software – i.e. Excel, Word, PowerPoint, Access, etc.
• Maintaining ethical professionalism by keeping personnel information confidential.
• Ability to work and communicate within a Team Environment
• Technical writing skills preferred.

Equipment and Applications

• Computer (applicable software)

Work Environment and Physical Demands (List required PPE’s)

• Required to don proper GMP gowning and PPE prior to entering production areas.
• GMP gowning includes lab coat with sleeves worn at wrist level and all buttons closed, hairnet, beard cover (if applicable), procedure mask, and gloves, both are required when working over any open product or componentry.
• Safety Glasses must be worn while inside of all production areas.
• Ability to occasionally lift up to 50 pounds.
• Must be able to sit for extended periods of time while reviewing documentation.
• Cubicle

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.