Packaging Specialist- 2nd Shift

Job Title

Packaging Specialist

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

927 Currant Rd., Fall River, MA

Employment Type 

Full Time

Work Hours/ Shift

Second Shift: 03:00 PM  – 11:30 PM (may vary based on business needs) 

Salary Range (Base/ Hourly) 

$72,800 – $93,600

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, employee discounts, and other benefits. 

Responsibilities/ Accountabilities

Assist in the coordination of daily packaging activities to meet production schedules of projects. 

• Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards.
• Identify and resolve operational inefficiencies, escalating complex issues when necessary.
• Ensure proper documentation of batch records, logs, and deviations.

• Monitor production schedules to ensure timely execution and minimize delays to support ongoing projects.
• Assist in investigating deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
• Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures (SOPs).
• Assist in coordinating materials, equipment, and workforce allocation for optimal resource utilization.
• Identify areas for operational improvements, focusing on reducing waste and enhancing efficiency.
• Assist in implementing new technologies and automation in production workflows.
• Collaborate with Team, Quality, Supply Chain, Project Management, Engineering, and R&D teams to resolve operational bottlenecks
• Support training efforts by ensuring clear communication of standard operating procedures (SOPs)
• Monitor operational metrics such as efficiency, compliance rates, and resource utilization.
• Identify areas for improvement in packaging activities and contribute to process enhancements.
• Support initiatives aimed at improving overall productivity through data analysis and performance reviews.
• Develop and maintain strong professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.
• Create and manage purchase requisition (PR) using SAP for services, contracts, equipment, consumables, and miscellaneous items, ensuring accuracy & alignment with end-user requirements.
• Maintain clear and effective communication with internal and external stakeholders to address issues, facilitate smooth operations, and ensure alignment with project strategies.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP).
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure that their working area is clean.
• Adhere to CIPLA’s Safety, Health, and Environmental policies.
• Other duties assigned as required by Reporting management / Dept. Head.
   

Education Qualifications

Bachelor’s degree in pharmaceutical sciences/ electrical/ mechanical / production or related fields of study.  

Experience

5-11 years of experience in packaging, operations, team management. Preference will be given to candidates with experience in pharmaceutical MDI packaging.

Skills/ Competencies

• Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes.
• Experience in SAP system and packaging data analysis tools.
• Strong problem-solving abilities, attention to detail, and ability to work in a fast-paced, regulated environment.
• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suited.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP), complying with legal regulations, monitoring the environment.
• Knowledge of pharmaceutical packaging and related documents.
• Knowledge and experience writing, revising, and creating cGMP records and SOP’s.
• Experience with quality system compliance.
• Ability to work effectively both independently and as part of a team.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Experience in Inhalation products (Metered Dose Inhaler) is a plus.

Physical Demands

Physical Demands: While performing duties of this job:

• Stand or walk for extended periods of time.
• Reach with hands and arms.
• Use fingers to handle or feel.
• Ability to lift up to 50lb when required. 
• Safety/Personal Protective Equipment (PPE) required for this job.