DPI Manufacturing Operator (Multiple Roles)

Job Title

DPI Manufacturing Operator

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Hauppauge, NY location

Employment Type

Full Time

Salary Range

(Base/ Hourly)

$16/hr - $22/hr

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, paid and unpaid family leave, employee discounts, and other benefits.

Work Hours/ Shift/ Remote

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.

Responsibilities/ Accountabilities

• cGMP/Documentation:  Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP).
• Accurately and legibly document in Manufacturing Batch Record and Logbook.
• Determine when to stop a line related to a safety or quality.
• Raw Materials and Equipment Checklist Successfully Completed
• Obtain and weigh in products for all shifts.
• Moves raw materials and product to/from vault, cage, process, or storage areas.
• Inspects machine parts for unusual wear and proper lubrication.
• Operates equipment required in the manufacture of pharmaceutical products.
• Performs/reviews quality checks on weight, thickness, hardness, and friability of Product at various stages of the process according to manufacturing instructions and SOPs.
• Submits product samples to quality laboratories as required.
• Maintains product batch, room activity, and equipment records.
• Assist in running validation batches.
• Monitors the production process, makes periodic checks, and adjusts equipment or work practices to maximize production efficiency, yields, quality, and safety. Accurately reports production and ensures reports are completed as required.
• Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up.
• Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production.
• Will immediately stop manufacturing and notify Line Leader or Supervisor of any safety or quality concerns.
• Perform line cleaning.
• Segregate waste product and materials.
• Return unused material/product.
• Disassembles, cleans, and reassembles basic line equipment according to SOPs. Ensures proper inspections are conducted prior to reassembly.
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure working area is clean.
• Adhere to CIPLA’s Safety, Health, and Environmental policies.
• Other duties assigned as required by Manufacturing Management.

Education Qualifications

• High School Diploma (or equivalent experience).

Experience

• Six (6) months Manufacturing Operator experience in an automated work environment preferred.

Skills/ Competencies

• Knowledge of current Good Manufacturing Practices (cGMP), Manufacturing Area Standard Operating Procedures and Food and Drug Administration (FDA) regulations
• Ability to communicate effectively and clearly, both written and verbally in English
• Comply with safety and quality regulatory standards.
• Ensure products are Manufacture in accordance with CIPLA/InvaGen standards.
• Works Independently:  Works independently with minimal supervision once assignments or responsibilities outlined and delegated.  Displays a strong sense of ownership for work.
• Flexible and Adaptable:  Copes with ambiguity, change and uncertainty effectively. Not hesitant to resolve lack of clarity, structure or definition of outcomes then moves ahead.
• Action and Results Oriented:  Demonstrates initiative, sense of urgency and bias for action.  Self-motivated, naturally proactive with high energy level when addressing work tasks.
• Communication:  Communicates effectively orally and verbally with supervisors and peers. Maintains and internal and external customer focus.
• Organized and Timely:  Uses organization and good time management skills.  Ensures tasks are completed within set deadlines.  Works effectively in a multitask environment and consistently tracks the progress of ongoing initiatives. 
• Prioritizes and Implements:  Identifies issues and opportunities, prioritize, and successfully implements them. Uses cognitive skills and processes to arrive at sound decisions and solutions.
• Logical Thinking and Analysis: Assimilates diverse information and proactively presents solutions through detailed analysis.  Balances logic and intuition to arrive at well-founded decisions tempered by practicality and common sense. 
• Relationship Builder: Builds productive, trusting, respectful relationships at all levels in the organization.  Understands and values the perspectives of others by working in teams.
• Continuous Improvement Focus:  Continually strives to learn more to improve self.  Sets high standards for work and work relationships.  Actively seeks and supports continuous improvement activities in process efficiencies, costs, and effectiveness of work.
• Effective Conflict Resolution Skills:  Using tact and diplomacy is effective in resolving differences and conflicts within the organization.  Good listener who takes care to understand the words of others, asking questions and actively acknowledges key points.
• Team Player:  Consistently acts as a member of the team.

Physical Demands

Physical Demands: While performing duties of this job:

• Stand or walk for extended periods of time.
• See, talk, hear, or smell.
• Sit, bend, push, pull, squat, kneel, climb, or balance.
• Reach with hands and arms.
• Use fingers to handle or feel.
• Lift up to 10 lbs 60% of the time
• Lift 10 – 24 lbs 30% of the time
• Lift 25 – 49 lbs 10% of the time
• Safety/Personal Protective Equipment (PPE) required for this job.