Manufacturing Specialist

Fall River, MA - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Role: Manufacturing Specialist - 1st Shift
Job Locations: Fall River
Required Experience: 5 - undefined Years

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.

Work Hours/ Shift

General Shift: 07:00 - 15:30 (may vary based on business needs)

General Shift: 15:00 - 23:30 (may vary based on business needs)

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

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.

Required Skills:

CGMPFDA REGULATIONS

Job Role: Manufacturing Specialist - 1st Shift Job Locations: Fall River Required Experience: 5 - undefined YearsBenefitsIn 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 - med...