Production Operator (II/III) / Sr. Operator 37092

Experience

4 – 20 Years

 

Position Description

Position Title: Production Operator II, III (Compression, Coating, Granulation, Encapsulation)

Job Code: Grade: (Compensation/HR Use Only)

Location: Chantilly, VA Department:

Production Operator II – III (Skilled Operators)- must have OSD Manufacturing experience

Pay rate: $ –  / hour

Job Summary

JOB SUMMARY

The Manufacturing/Production Operator performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

Principle Accountabilities

Entry Level & Highly Skilled Pharmaceutical Production/Manufacturing Operators

Key Accountabilities:

Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.

Executes written SOPs to ensure the purity of materials involved in the manufacturing process.

Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.

Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.

Cleans manufacturing equipment and facilities according to established SOPs.

Executes machine changeovers from batch to batch.

May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.

Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.

Documentation:

? Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.

? Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.

? Verifies the manufacturing process on BPR in an accurate and timely manner.

? Provides status updates and operational challenges on status boards.

Continuous Improvement:

? Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.

? Typically participates in at least one continuous improvement project of a moderate scope and complexity.

Safety & Compliance:

? Adheres to all cGMP compliance/regulatory mandates and quality requirements.

? Participates in safety teams, start-up discussions, incident debriefing sessions, etc.

? Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.

? Maintain a clean, organized, work area.

Training:

? Conforms to all training requirements, including company required and machine-specific training.

Teamwork & Collaboration:

? Contributes to team and project success by sharing previously acquired knowledge.

? Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.

Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.

Attendance/Punctuality – Is consistently at work and on time; Arrives at meetings and appointments on time.

Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.

Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.

Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

? Comply with all Company policies and procedures.

? Comply with all Company safety rules and regulations.

Management Responsibility

Reports to

Production Manager

Internal/External Contacts

Knowledge & Skills

Current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements

Standard Operating Procedures for process rooms and manufacturing area

GMP compliance in a regulated work environment

Manufacturing processes and equipment procedures

Required Skills & Abilities:

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

? Proficient in running machinery.

? Proficient in (Master Clean/Surface clean) equipment cleaning.

? Proficient in sampling batches.

? Proficient in doing basic set-ups.

? Ability to participate in Continuous Improvement projects.

? Qualified in any of the following manufacturing processes:

? Weighing

? Blending

? Granulation

? Compression

? Coating

? Encapsulation

? Potent Compound

Experience & Education

High School Diploma or equivalent experience

Any production or retail store experience

Knowledge of Good Manufacturing Practices (cGMP)

Looking for Pharmaceutical Glatt, Compression and Pan coating experience

•  

• Level II Operator:

  HS diploma, GED or College Associate Degree

  Minimum of 2-5 years of pharmaceutical manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.

  Forklift certification may be required for certain jobs.

• Level III Operator:

  HS Diploma, GED or College Associate Degree

  Minimum of 5+ years of pharmaceutical manufacturing experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.

  Forklift certification may be required for certain jobs.

Knowledge:

Strong background in solid dose manufacturing specific to Compression OR Encapsulation OR Coating OR Wurster Coating

Experience in Pharmaceutical Granulation and Blending experience a potential plus.Capable of cleaning, setting-up and operating state of the art equipment including but not limited to : tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12.

Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.

Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.

Basic math, reading, legible writing skills, and problem-solving abilities.

Physical Requirements/Working Environment

Physical Requirements:

? Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

Travel

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.