Packaging Coordinator-3rd Shift

Cosette Pharmaceuticals Inc.; Lincolnton (NC); On-site; USD 25,000 - 39,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is seeking an Administrative/Technical Support specialist for Packaging Operations to assist with QAD transactions, maintain and organize production records, and review records for bulk accountability.

The role supports Supervisors with training coordination, ensures accurate documentation, and maintains cleanliness and compliance with cGMP and safety policies in a fast-paced manufacturing environment.

Qualifications

• High school diploma or equivalent.
• Pharmaceutical manufacturing experience desirable.
• Thorough knowledge of QAD preferred.

Responsibilities

• Perform Packaging department QAD transactions and inventory entries.
• Maintain and organize production records for accuracy.
• Review records for bulk accountability and reconcile errors.
• Ensure correct SOF/SOP control and change management.
• Assist with training coordination and ensure timely completion.
• Maintain clean and sanitary work area and adhere to GMP policies.
• Support shift operations and assist with line allocations as needed.
• Audit packaging lines for SOP revisions and compliance.

Skills

QAD

Excel

Windows OS

Technical writing

Teamwork

Education

High school diploma or equivalent

Tools

QAD software

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