Grifols Shared Services North America, Inc Technical Training Specialist in Los Angeles, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals, pharmacies, and healthcare professionals with the tools, information and services they need to deliver expert medical care. Grifols’ three main divisions – Bioscience, Diagnostic & Hospital – develop, manufacture, and market innovative products and services available in more than 100 countries. At Grifols we are united around a strong sense of pride, operating under the highest standards for quality and safety.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. We would love for you to consider growing your career with us. If challenging and meaningful work excites you, make a difference and join us in this rewarding enterprise!
Responsible for technical, and cGMP training for new and existing employees. Works closely with various department managers to develop programs and plan curriculum. Actively participates in site training programs to ensure the highest level of compliance and conformance to procedures that are specified by BPRs (batch production records), SOP’s, cGMP’s and GBI standards.
Essential Job Duties:
Work with management to design, develop and implement comprehensive, competency-based training programs following sound instructional design methods for cGMP and technical courses.
Conduct On-The-Job Training of cGMP and technical courses on a one-on-one or group environment.
Leverage knowledge and best practices to continuously improve personnel technical competency.
Ensure technical training needs for cGMP departments are met.
Identify patterns or trends within GBI / department and recommend / provide appropriate training interventions.
Ensure technical training program and personnel adhere to cGMP, Quality, Safety and Compliance standards.
Provide feedback to management on training status and progress of personnel.
Provide technical advice and counsel in the identification of training needs and development of on-the-job training and qualification programs.
Provide the highest level of service to our internal customers, i.e. manufacturing group.
Monitor and report monthly technical training accomplishments.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Bachelor's Degree is required. Degree in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred.
Minimum 4 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.
Equivalency: In lieu of a Bachelor's degree, candidate must have an AA degree, and a minimum of 6 years of experience in a pharmaceutical, GMP, or FDA regulated environment.
Technical training experience conducting one-on-one and/or small group training is preferred.
Requires a basic understanding of instructional design, adult leaning theory, facilitation, and web-based training.
Fractionation experience is required, with strong working knowledge of departmental processes and procedures.
Comfortable speaking in front of small to medium size (2-20 people) groups.
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Ability to work independently with minimum supervision.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
*This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 85554
Type: Regular Full-Time
Job Category: Manufacturing