Department Training Associate en AVEVA DRUG DELIVERY SYSTEMS INC

Description

Job Responsibilities:

· Trains and qualifies department personnel for all required documents with the support of the subject matter expert if necessary.

· Active participation supporting the onboarding new hires with cero deviations or safety incidents.

·· Demonstrate curiosity and creativity to effectively managing training options to remain compliant to the company policies and procedures

· Acts as point of contact for submission of training records and review for completeness and accuracy.

· Communicates with authors of procedures that impact department training requirements, and ensure notification to employees regarding training.

· Schedules and coordinates training sessions for new or revised documents and follow up until 100% completion.

· Requests and prepares material to support training activities.

· Support and coordinate training with Production employees in TMS

· Support the business projects

· Actively participate on monthly walkthroughs in Production areas and warehouses in collaboration with Production.

· Compliant with former monthly "EHS Perspectives" in collaboration with EH&S and Production departmens

· Demonstrates commitment to be a safety leader and inspires others to work safely, far exceeding expectations. Proactively coaches colleagues to work safely.

· Available to support training audits by running/customizing reports as need it.

· Support on creation and changes on AVEVA's SharePoint to keep Production supervisors and managers updated with new/current employees training status during the transition from a Manual Training Process to TMS training Process (Difgen).

· Support on assignment of documents (i.e, SOPs, WIs, STPs, PPMs, etc) to Production employees based on training plans.

· Creation and update of Qualification Modules

· Timely entering and updating of qualification metrics to reflect training status of employees available to work with product

· Conducting trainings in Production overlap times to avoid stopping the Production Lines or paying packaging employee's overtime.

· Enables training completion by influencing others towards a compliance mindset.

· Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Pride, Accountability, Intergrity and Diligence.

· Demonstrates strong and visible support of our values

· Performs all work in accordance with all established regulatory and compliance and safety requirements

· Works as a member of a team to achieve all outcomes.

· Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.

· Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.

· Displays a high level of GMP and GDP knowledge.

- Complete tasks within the scheduled workday to avoid overtime

· All other relevant duties as assigned

Qualifications

Job Requirements

· Education

o Associates (A.A./A.S) or Bachelor's (B.A./BS. degree in Science, Business or related discipline preferred

Experience

• A.S. or B.S. degree- A minimum of 3 years of relevant pharmaceutical experience in a fast-paced lean Manufacturing/Packaging/Manufacturing organization in a GMP environment

· Knowledge, Skills and Abilities

o Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.

o Knowledge of Aveva's current packaging or manufacturing process. 

o Knowledge of FDA, cGMPs, and SOPs related to job requirements.

o Ability to speak English and interpret documents and Batch Records.

o Ability to write and word process English

o Ability to speak English effectively and communicate with all company employess

o Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals

o Must possess intermediate to advanced Microsoft Excel, Word, PowerPoint and Access software knowledge

o Highly organized and detail oriented.

o Demonstrated ability to handle multiple priorities in a fast-paced environment.

o Flexible schedule to assist with training and qualification in all 3 shifts

o The employee is frequently required to walk or stand

o The normal work environment for this position is an office/manufacturing setting

o The noise level in the work environment is usually moderate

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