Manufacturing Operator l
Job Summary - a concise overview of the job
The Manufacturing Operator I 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. Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput and quality. Learns, understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate 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.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Manufacturing Operations work unit at the various Par locations listed above
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, 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.
§ Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.
§ Executes machine change-overs from batch to batch.
§ Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.
§ Learns sampling techniques.
§ Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward.
§ 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.
§ Learns to troubleshoot process issues with guidance. Refers deviations from standard procedure to the supervisor.
§ May participate in continuous improvement projects.
Safety & Compliance
§ Carries out processing/manufacturing activities safely, as required, on a daily basis.
§ Follows all safety and compliance procedures and participates in required training.
§ Adheres to all cGMP compliance/regulatory mandates and quality requirements.
§ Participates in safety teams, start-up discussions, and incident debriefs, etc.
§ Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
§ Maintains a clean, organized work area.
§ Conforms to all training requirements, including company required and machine-specific training.
Teamwork & Collaboration
§ Learns the responsibilities of being a team member.
§ Contributes to team and project success by sharing novel insights.
§ Collaborates typically within own cross-functional work unit.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ HS diploma or equivalent at minimum, with 0-2 years’ related experience*
§ Forklift certification may be required for blending and granulation.
* Preferred experience: operations work in any industry, machinery operation, shift work, experience working with quality issues or productivity, military experience, basic mathematical & writing aptitude
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Learns cGMP regulations and processes.
§ Basic math, reading, legible writing skills, and problem solving 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.
§ Ability to learn and perform (master clean/surface clean) equipment cleaning.
§ Ability to learn to perform basic set-up.
§ Ability to learn and perform sampling.
§ 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.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ 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.
§ Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
§ Vision - ability to see details at close range (within a few feet of the observer).
§ Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness.
§ Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.