Packaging Coordinator-3rd Shift

cosettepharma; Lincolnton (NC); On-site; USD 32,000 - 42,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is seeking an enthusiastic packaging operations helper to provide administrative and technical support. You will perform QAD transactions, maintain production records, and review records for accuracy, ensuring timely changeovers and reconciliation.

The role requires adherence to GMP and safety policies, and collaboration with Supervisors on training and line assignments. A high school diploma is required, with pharmaceutical experience preferred.

Qualifications

• High school diploma or equivalent.
• Pharmaceutical manufacturing experience desirable.
• QAD knowledge preferred.
• Good PC skills and MS Office familiarity.

Responsibilities

• Perform Packaging department related QAD 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 and cGMP requirements.
• Assist Supervisors with SOP training coordination and completion tracking.
• Attend daily production meetings and distribute updated production sheets.
• Month End Inventory duties.
• Other duties as assigned by Supervisor.

Skills

Teamwork

Technical writing

Confidentiality

Education

High school diploma or equivalent

Tools

Windows-based software (Excel, Word, PowerPoint, Access)

Job 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