Operator III, Packaging - 2nd Shift

Registered Client Service Associate

Manufacturing Operator III

Role Description: <ul><li>With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. </li><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department. </li><li>Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.</li></ul> Responsibilities: Packaging Operations: <ul><li>Is qualified and capable of competently running all packaging equipment across the entire packaging department</li><li>Is qualified in both Filling and Labeling</li><li>Ensures that all equipment is running properly</li><li>Executes processes such as material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartooning, etc.</li><li>May request components, labels and inserts per the BPR</li><li>Sets up packaging machinery; accurately sets equipment programming according to BPRs and SOPs</li><li>Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines</li><li>Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy</li><li>Accurately reviews BPRs steps for completeness and accuracy</li><li>Collects samples from each batch and submits to QA for retained samples</li><li>Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner</li></ul> Equipment Cleaning: <ul><li>Conducts verification of line/equipment cleaning and documents per SOP</li><li>Executes the procedures used to clean pharmaceutical packaging equipment and facilities</li><li>Conducts Master Cleans and Surface Cleans</li></ul> Continuous Improvement : <ul><li>Identifies 6S opportunities and sustains the 6S process</li><li>Assists in troubleshooting process issues</li></ul> Issues and Deviations: <ul><li>Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.</li></ul> Quality: <ul><li>Executes the required in-process product quality checks and documents accurately.</li></ul> Teamwork and Collaboration: <ul><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li></ul> Training: <ul><li>Stays current on SOPs and cGMPs.</li><li>May participate in training qualifier classes.</li></ul> Safety and Compliance: <ul><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Carries out processing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies</li></ul> Misc.: <ul><li>Other related duties as assigned to meet departmental and Company objectives.</li></ul> Requirements: Education &amp; Experience: <ul><li>High school diploma or equivalent.</li><li>3 years of packaging experience</li></ul> Knowledge &amp; Skills: <ul><li>Knowledge of cGMP regulations and processes.</li><li>Qualified in both Filling and Labeling</li><li>Qualified and capable of setting up and running all machinery in the value stream</li><li>Competent in Master Clean/Surface Clean</li><li>Ability to sample batches</li><li>Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation</li><li>Ability to accurately and precisely record data and batch information</li><li>Ability to work in both independent and team environments</li><li>May become a certified trainer and provide certified training in one process</li><li>Effectively interfaces with other department personnel if Senior level (4th level) isn’t available</li><li>Ability to troubleshoot process issues</li><li>Ability to Identify 6S opportunities and sustain the 6S process</li><li>Ability to participate in Continuous Improvement projects</li><li>Proficient in reading and writing English to understand work instructions and document results</li></ul> Physical Requirements: <ul><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or 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.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>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.</li></ul>

Responsibilities: <ul><li>Assist advisor(s) in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions as described by the advisor.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, entering data into contact manager, building the agenda and summary of meetings, escorting clients to advisor meeting and providing vital follow-up.</li><li>Ensure new business paperwork is submitted efficiently which includes preparation of forms and documentation for submission to home office, acquisition of appropriate signatures, tracking of new insurance applications and coordination of rollovers.</li><li>Coordinate marketing events which include organizing the event, contacting vendors, finalizing event details, crafting marketing compliance documentation and managing event marketing reimbursement.</li><li>Provide general administrative duties such as answering the advisors’ phone, processing expense management reports, preparing routine client correspondence, supporting closes, setting up client documents and new business correspondence and alerts. </li></ul> Requirements: <ul><li>Bachelors degree or equivalent.</li><li>3 - 5 years relevant experience required.</li><li>Series 7 or ability to obtain within 150 days.</li><li>State securities agent registration (S63 or S66) or ability to obtain within 150 days.</li><li>Experience working in a client service environment.</li><li>Detail-oriented, strong math, and analytical skills. Good organization and time management skills.</li><li>Able to manage multiple priorities and prioritize effectively. Able to independently work with minimal direct supervision.</li><li>Able to communicate with all levels within the organization. Process oriented and can work with a team.</li><li>Strong computer and software skills. Preferred Qualifications:</li><li>State IAR registration (S65 or S66) or ability to obtain within 150 days.</li><li>Life, Accident, and Health licenses &amp; Variable Contracts or ability to obtain within 150 days.</li></ul>

Responsibilities:The Manufacturing Operator III 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.  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.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 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.Completes documentation associated with manufacturing processes (e.g. batch record, protocol, 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. 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.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.May become a certified trainer and provide mentoring and trainingExhibits 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.Requirements:HS diploma or equivalent at minimum, with 0-2 years’ related experience*Forklift certification may be required for blending and granulation.Ability to read a tape measureAbility to demonstrate safe and effective operation of all required equipmentApplies skills and knowledge to recognize issues and to increase efficiency, throughput and quality.

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Operator III, Packaging - 2nd Shift

Registered Client Service Associate

Manufacturing Operator III

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Operator III, Packaging - 2nd Shift

Registered Client Service Associate

Manufacturing Operator III

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