Training And Document Control Systems Specialist

Masy Systems Pepperell , MA 01463

Posted 3 months ago

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Description

Masy BioServices is a 35-year-old family owned business which has experienced rapid growth over the past several years. Masy currently has four locations and over 160 employees. We provide services to pharmaceutical, biotech and medical device industries.

Our reputation has been built around the quality and experience of our staff. We have carefully built a dynamic team whose members possess diverse professional skills. We offer a casual, friendly atmosphere, promoting individual development, career growth and industry association opportunities.

We offer competitive salaries and an excellent benefits package including a matching 401K, health, dental, short term and long term disability and life insurance. We also offer holiday pay, PTO, education reimbursement, AAA membership and a clothing allowance.

Masy BioServices is an equal opportunity employer.

Job summary:

This position provides training and document control support for the company's quality management system. Duties include training design, development, implementation and logistics, as well as Document Control review and approval. This position requires frequent interaction with multiple departments, and working independently with supervision of management or team lead.

Duties/responsibilities:

  • Collaborative design and development of training curricula and materials

  • Measure and monitor effectiveness of training

  • Coordinate the logistics of assigning and documenting training within ZenQMS

  • Executes the day to day activities in the following programs:

o Training

o Document Control / Record Retention

  • Participate in employee onboarding, including aspects of New Hire Training

  • Facilitate Train the Trainer and additional trainings as needed

  • Author, review, and approve documents, and update controlled distribution locations

  • Maintain and destroy Quality Records in accordance with record retention policy

  • Perform Investigations, Root Cause Analysis and Corrective Action activities in relation to training and document control

  • Cross train in other Quality System tasks

  • Assist team members with internal audits, round robins or additional QMS required activities

  • Lead or help to lead small to medium department projects or special assignments with deadlines. May require report writing.

  • Other duties as assigned

Requirements

Preferred education/Experience requirements:

  • 4 year degree in related field or equivalent work experience
  • 3+ year(s) related experience designing and delivering training curricula

Additional experience/skills:

  • Relationship and interpersonal skills to ensure stakeholder and SME engagement

  • Knowledge of adult learning theory

  • Instructional design

  • Strong facilitator and presentation skills

  • Demonstrated ability to multi-task and prioritize

  • Team player with strong sense of responsibility

  • Strong written and verbal communication skills

  • Strong organizational skills

  • Proficient with Microsoft Word, Excel, PowerPoint and Outlook

  • Knowledge of ISO 9001, ISO 17025 and GMP a plus

Physical Demands:

  • Drug testing, inoculations may be required

  • Typical environment is office, laboratory and biorepository

  • Ability to lift 25 lb

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Training And Document Control Systems Specialist

Masy Systems