Shift Trainer: Level II - Albuquerque, United States - curiate

Description

Shift Trainer II in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Manufacturing Training Department provides ongoing training to existing operators in the aspects of the Sterile University (SU) program, gowning training as it applies to compounding, new SOP, SOP revision training, and pre-manufacturing meetings. The Manufacturing Training Department assists the functional areas with the creation of testing and evaluation criteria.

The Manufacturing Training Department coordinates, schedules, and conducts technical skill-based training. The Manufacturing Training Department interfaces with production Team Leads, Set-Up techs, and Supervisors for their specific department. The trainer will develop and implement training modules and manuals for manufacturing employees. Recommends, implements, and administers training to enhance employees' work performance. The trainer will develop knowledge/skill assessment testing for employees in line with department/job requirements. Performs training needs assessment/analysis and initiates, designs, and coordinates the implementation of specific technical skills training for manufacturing employees. Training technicians will be Responsible for maintaining training records and databases for trainees/new hires.

Under the general supervision of the Training Supervisor, the Sterile University Trainer develops, coordinates, and conducts training (technical skill-based) for compounding production employees with an emphasis on equipment operation, theory, and basic techniques. The Sterile University Trainer is responsible for developing training modules and manuals within a framework provided by the training department for compounding manufacturing personnel. Accountable for conducting needs assessments utilizing needs assessment tools offered by the training department for all manufacturing technical skill-based training. Responsible for maintaining the training record databases for manufacturing trainees. Evaluate trainee's performance and recommend retraining or release to appropriate department supervisor. Creates and maintains metrics, then communicates information regarding those metrics with area supervisors. The trainer will perform annual re-qualification certifications.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients lives with the pharmaceuticals we develop and manufacture.

Essential Duties and Responsibilities include the following.

+ Provide corrective action training based on Quality Dept. audits by providing remediation training in cGMP aseptic manufacturing. Partner with HR/Operations/Quality Leadership to make recommendations for enhancements to aseptic processes

+ Review Training Gap Assessments for all shifts and delivery and or coordinate technical training. Presence in Classroom and Manufacturing filling areas is required. As a (SME) subject matter expert, responsible for partnering with Quality as well as Manufacturing to training personnel in Aseptic Techniques and cGMP manufacturing processes.

+ Coordinates, schedules, and conducts technical skill-based training based on SU curricula. Recommends, implements, and administers OTJ and classroom training to enhance employee work performance

+ Performs training needs assessments/analysis (using provided tools) and initiates, develops, and coordinates the implementation of specific technical skills training for manufacturing employees based on the assessment, with oversight and approval of the training supervisors.

+ Develops knowledge/skill assessment testing using provided tools for employees in line with department/job requirements designed in the SU program

+ Develops and implements training modules and manuals utilizing a provided framework and with training department approvals for manufacturing employees

+ Establishes and maintains logs, metrics, filing, and record-keeping systems and ensures that all relevant training records are complete, accurate, and up-to-date for all initial training and retraining of manufacturing employees

+ Establishes/maintains annual retraining certifications for all manufacturing employees

+ Coordinates pre-manufacturing meetings that will review all relevant documentation for a specific process

+ The trainer will interface with manufacturing personnel for their specific department. Other duties may be assigned.

Supervisory Responsibilities:

This job has no supervisory responsibilities

Education and/or Experience

Bachelor's degree in Training and Development, and or related field. or previous experience professional preferably in Pharmaceutical Manufacturing or a related field or equivalent experience with three (3) years of previous professional experience. At least three (3) years working with a (LMS) Learning Management System. The ability to gown and work daily in an aseptic manufacturing environment. cGMP experience in an FDA-regulated pharmaceutical environment. Actual experience training (ILC) Instructor Lead Courses, ad hoc training, and blended training delivery. Knowledge of ADDIE and ability to conduct training gap assessments.

Language Skills:

Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Have the ability to write and edit technical documents, SOPs, write instructions, reports, business correspondence, and procedure manuals. Have the ability to effectively present information and respond to questions from groups of supervisors, clients, customers, and the general public.

Mathematical Skills:

Ability to apply basic math concepts.

Reasoning Ability

Have the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Computer Skills:

Proficient in Microsoft Excel, Word, and PowerPoint. Basic quality tools (i.e. Pareto charts, histograms, cause-and-effect, root cause analysis).

Other Skills and Abilities

+ Ability to present to small and large audiences

+ Excellent communication skills, both verbal and written

+ Ability to organize a time to manage multiple projects and priorities successfully

+ Ability to read, understand, interpret, and implement technical writing and instructions.

+ Practical interpersonal relation skills while maintaining the adaptability to achieve company goals

+ Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style.

Other Qualifications:

Must pass a background check

Must pass a drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee must frequently sit and use their hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl. The employee must regularly lift up to 10 pounds, frequently lift and move up to 25 pounds, and occasionally lift and move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is frequently exposed to moving mechanical parts; high, precarious places; risk of electrical shock, explosives, radiation, and vibration risks. The employee is occasionally exposed to extreme cold, heat, and wet and humid conditions. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and perform any other job-related duties requested by anyone authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to accommodate individuals with disabilities reasonably. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.