Current Open Jobs & Employment Oppportunities | Insperity

Training Documentation Specialist, Bilingual Spanish and English Preferred

Job Title
Training Documentation Specialist, Bilingual Spanish and English Preferred
Job ID
27489875
Location
CARROLLTON,  TX 75006
Other Location
Description

Swiss American CDMO LLC is a topical drug, skincare, wound care, and medical device developing and manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing, and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment.” Are you passionate about Service Excellence, Results, Integrity, and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.

Training Documentation Specialist, Bilingual Spanish and English Preferred

Under the supervision of the Manager of Training, the Training Documentation Specialist is responsible for assisting with the monitoring and implementation of Swiss American’s (SA) training program with primary responsibilities including documentation reconciliation, follow-up on outstanding training, filing and scanning of training records as well as general administrative training duties. Responsibilities also include supporting the training of employees through onboarding, GMP training, ad-hoc training requests, and data entry activities as well as assisting with the creation of training content as needed for the Training Department.

Essential Duties and Responsibilities:

  • Support communication with all departments to schedule and deploy necessary training requirements and documentation of training activities per procedures.
  • Assist with the research, recommendation, and creation of new training material and/ or methods as well as training effectiveness methods. (This can include video production.)
  • Assist with ensuring applicable new employees complete initial Swiss-American Orientation/ Onboarding training
  • Scan and file of training records into the electronic file system, update spreadsheets and monitor completion of training-related activities linked to Change Management records, Adhoc Training requests, SOP training, DCN reconciliation, etc.
  • File and maintain all physical filing for training documentation; demonstrate effective organizational skills, time management skills, and ability to work in a team or individually.
  • Assist with ensuring appropriate employees complete annual GMP training
  • Assist with ensuring all applicable employees are trained on new or revised SOPs
  • Adhere to Good Documentation Practices, company procedures, and cGMP requirements
  • Assist implementation and maintenance of UniPoint training module to be utilized for all training records.
  • Assist in SOP change request pre-implementation process as well as performing wet-signature approval process;
  • Assist in the DCN portion and training distribution of the SOP approval process;
  • Assist in the Annual Review of training files, department book updates, and uniPoint training event audit process, as necessary.
  • Assist in assuring SOP index, Electronic share files, SOP master files, and uniPoint Training Module agree.
  • Conduct virtual and in-person training sessions as assigned. Including but not limited to weekly recurring onboarding sessions and training sign-off sessions. (Sessions may require multi-site visits.)
  • Assist with audit support for training documentation when necessary.
  • All other duties and responsibilities assigned

Qualifications:

  • Bilingual Spanish and English Preferred
  • High School diploma or equivalent
  • Industry experience in a Training function required with at least 1 year in a manufacturing environment for Cosmetic, Drugs, and/or Medical Device products (or equivalent experience)
  • Familiarity with industry regulations and standards, FDA expectations regarding training.
  • Industry experience with document control preferred.
  • Proficient in Microsoft Office Business Suite and in database and Internet software. Proficiency in Word, Excel, and PowerPoint is required.
  • Adequate knowledge of learning management software.
  • Proficiency in Video editing is preferred.
  • Bilingual in reading, writing English, and Spanish preferred.

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match, and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.