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Operations Supervisor

Fall River, Massachusetts · Administrative
Primary Responsibilities:
  • Plan, organize and oversee all activities related to the manufacturing and packaging of MDIs to include batch planning, operations, troubleshooting and shift personnel management.
  • Review and compile the documents generated during the production of MDIs such as batch records and protocols (i.e. validation protocols, qualification protocols, etc.).
  • Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations.
  • Evaluates various stations of the production operation to ensure optimum efficiency and follow through.
  • Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed.
  • Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches.
  • Coordinate with departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives.
  • Ensure the process flow of raw materials, supplies, and other resources.
  • Provide daily supervision and support to operators in daily production activities such as trouble shooting and other work tasks.
  • Follow production schedules, ensures quality standards, and handle technical and administrative issues on assigned shift.
  • Maintain communication between employees and upper management to ensure procedures and policies are understood.
  • Assist with recruiting, hiring, training, motivating, and evaluating the performance of a diverse manufacturing team.
  • Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements.
  • Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
  • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
  • Documents production by completing forms, reports, logs, and records of equipment and batches.
  • Update job knowledge by participating in training opportunities.
  • Maintain accurate and clear documentation that proves that manufacturing is being carried out in accordance with both internal and external quality systems or regulations.
  • Keep maintenance logs for all of the machines or processes they oversee, which requires proficiency in word processing and spreadsheet software.
  • Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
  • Other duties as assigned.

Education and Experience: 
  • Bachelor’s degree in Pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required.
  • Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
  • 1-3 years of direct work experience in pharmaceutical manufacturing.
  • Technical Knowledge and Computer Systems Skills
  • Understanding of machines used in pharmaceutical manufacturing.
  • Capable of conducting troubleshooting, investigations and root cause identification and analysis.
  • Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
  • Must be proficient in computer skills and software applications such as Microsoft Office tools.
  • Experience using SAP business system and applications is a plus.
  • Experience in Inhalation products (MDI) is a plus.
  • Professional and Behavioral Competencies
  • Proficiently speak English as a first or second language
  • Ability to understand and analyze complex data sets.
  • Knowledge of statistical packages is a plus.
  • Knowledge of good manufacturing practices and good documentation practices preferred.
  • Ability to read, write and communicate effectively.
  • Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
  • Excellent organizational skills with the ability to focus on details.
  • Basic computer skills (Word and Excel) – Intermediate
  • Good basic math knowledge and excellent attention to details.
  • Work Schedule and Other Position Information:
  • Must be willing to work in a pharmaceutical manufacturing setting.
  • Must be willing and able to work any assigned shift ranging from first, second, or third shift.
  • Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
  • Must be willing to work some weekends based on business needs as required by management.
  • Relocation negotiable.
  • No remote work available.
  • No employment sponsorship or work visas.
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