Operator III, Packaging - 2nd shift

Packaging TechnicianWith 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. Is qualified and capable of competently running all packaging equipment across the entire packaging department. 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.Essential FunctionsIs qualified and capable of competently running all packaging equipment across the entire packaging departmentIs qualified in both Filling and LabelingEnsures that all equipment is running properlyExecutes processes such as: material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartoning, etc.May request components, labels and inserts per the BPRSets up packaging machinery; accurately sets equipment programming according to BPR's and SOP'sSets up, starts, operates, adjusts, troubleshoots and tears down packaging linesExecutes Batch Production Record (BPR) and logbook documentation with detail and accuracyAccurately reviews BPR's steps for completeness and accuracyCollects samples from each batch and submits to QA for retained samplesDemonstrates the ability to execute procedures and complete tasks in a compliant and safe mannerEquipment CleaningConducts verification of line/equipment cleaning and documents per SOPExecutes the procedures used to clean pharmaceutical packaging equipment and facilitiesConducts Master Cleans and Surface CleansContinuous ImprovementIdentifies 6S opportunities and sustains the 6S processAssists in troubleshooting process issuesIssues and DeviationsIdentifies and reports processing related issues to Packaging Supervisor and to Quality personnel.QualityExecutes the required in-process product quality checks and documents accurately.Teamwork and CollaborationDemonstrates the ability to work in collaboration with others as a part of a team.TrainingStays current on SOPs and cGMPs.May participate in training qualifier classes.Safety and ComplianceParticipate in safety teams, start-up discussions, incident debriefs, etc.Carries out processing/packaging 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.Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agenciesMisc.Other related duties as assigned to meet departmental and Company objectives.QualificationsEducation & ExperienceHigh school diploma or equivalent.3 years of packaging experienceKnowledge & SkillsKnowledge of cGMP regulations and processes.Qualified in both Filling and LabelingQualified and capable of setting up and running all machinery in the value streamCompetent in Master Clean/Surface CleanAbility to sample batchesAbility to follow both verbal and written instructions including SOP's and Batch Record documentationAbility to accurately and precisely record data and batch informationAbility to work in both independent and team environmentsMay become a certified trainer and provide certified training in one processEffectively interfaces with other department personnel if Senior level (4th level) isn't availableAbility to troubleshoot process issuesAbility to Identify 6S opportunities and sustain the 6S processAbility to participate in Continuous Improvement projectsProficient in reading and writing English to understand work instructions and document resultsPhysical RequirementsMust 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.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).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.