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)

$72800 $93600

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 Ciplas 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 CIPLAs Safety Health and Environmental policies.
• Other duties assigned as required by Reporting management / Dept. Head.
  

Education Qualifications

Bachelors 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 SOPs.
• 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.