Strides Pharma

Job Summary -

The Manufacturing Operator III – Granulation 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. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options.  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.  Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.  Responsible for the safe and efficient execution of job duties.     May serve as back-up to the Senior Manufacturing Technician.

Manufacturing Operations work unit at the various Strides locations listed above

Accountability / Responsibilities

Manufacturing Process

• Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, mixing, granulating, drying, milling, blending, potent compound, etc.     Meets 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 change-overs from batch to batch.
• Completes a variety of assignments independently based on established procedures.
• Identifies process improvements that drive increased efficiency, throughput and quality.
• May sample batches, including validation 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 debriefing sessions to understand the reasons why and what needs to be corrected moving forward.

Documentation

• Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks and E-logs) 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.

Continuous Improvement

• Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations.  
• Typically participates in Continuous Improvement projects of a higher scope and complexity.

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.

Continuous Training

• Conforms to all training requirements, including company required and machine specific training.  
• May become a certified trainer and provide mentoring and training.

Teamwork and collaboration

• Exhibits team work and motivates others to achieve project objectives.
• Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.

Education & Experience

• HS diploma or equivalent at minimum, with 2-3 years’ related experience*
• Forklift certification may be required for blending and granulation.

Knowledge

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Knowledge of cGMPs.
• Basic math, reading, legible writing skills, and problem solving abilities.
• Has thorough knowledge and skills in the processes noted below. 
• Has a wide range of technical skills and operational knowledge.
• Understands the practical applications to problems and situations ordinarily encountered.

Skills & Abilities

• Proficient in running machinery.
• Proficient in (Master Clean/Surface clean) equipment cleaning. 
• Proficient in setting up machinery.
• Proficient in trouble shooting.
• Ability to become a certified trainer and provide certified training in one process.
• Ability to effectively interface with other departments if senior level (4th level) isn’t available. 
• Ability to participate in Continuous Improvement projects. 
• Posesses capability to be Qualified in multiple locations within the Granulation department and/or cross trained in Blending (where applicable) and at least one of the following manufacturing processes:
• Granulation
• Compression
• Coating
• Encapsulation
• Potent Compound
• 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 Requirements

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.