Training And Document Control Systems Specialist

Masy Systems Pepperell , MA 01463

Posted 3 months ago

Apply

This Job is not relevant Tell us why

Apply

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

Show Full Description

See how you match
to the job

Upload my resume

Download the
LiveCareer app and find
your dream job anywhere

Similar Jobs

View All

Want to see jobs matched to your resume?
Upload One Now!

Training Program Designer And Administrator

Masy Systems

Posted 3 months ago

VIEW JOBS Apply 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 designs, develops and implements the company's training strategy. Duties include instructional design, material coaching of other trainers, training facilitation and logistics. This position requires frequent interaction with multiple departments, and working independently with supervision of management or team lead. Duties/responsibilities: Training Program Design * Perform needs assessment and gap analysis to determine appropriate actions * Design overall training program structure * Author the Annual Training Plan * Collaborative design and development of training curricula and materials * Measure and monitor effectiveness of training Training Program Execution * Lead and coach trainer specialists across the company * Facilitate Train the Trainer and additional trainings as needed * Coordinate the logistics of assigning and documenting training within ZenQMS * Participate in employee onboarding, including New Hire Training * Author procedures and work instructions Additional Responsibilities * Perform Investigations, Root Cause Analysis and Corrective Action activities in relation to training * 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 * 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

HvacR Licensed Specialist III

Masy Systems

Posted 7 months ago

VIEW JOBS Apply Description Job Summary: This position is responsible for performing routine and emergency maintenance on Masy's biorepository, laboratory and building refrigeration, air conditioning and heating systems. Availability is required to respond to equipment failures. A high level of precision and accuracy is necessary for this position. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each. The person in this role will perform routine preventive maintenance and repairs for equipment belonging to Masy and their customers. This position is also responsible for creating, modifying and executing procedures and reports. Troubleshooting is also required as well as performing repairs and making recommendations about quality issues as they relate to maintenance and repair work. Document all work through the Maintenance Request Program. Duties: * Monitor and maintain Masy's refrigeration, HVAC and building systems and equipment by performing PMs and responding promptly to equipment failures * Monitor, predictively maintain and troubleshoot Masy HVAC and refrigeration systems through visual inspection and data input of the predictive monitoring system * Be able to troubleshoot and maintain all calibration lab equipment including temperature baths and humidity chambers * Identify, order and maintain an inventory of spare parts for applicable Masy equipment * Perform PM's and regular maintenance on Masy's back-up generators * Be able to troubleshoot and fully repair/maintain complex equipment * Develop and modify PM checklists as required * Be able to gather and document data to justify projects * Lead projects, perform work and/or coordinate work with outside contractors as needed to complete projects * Maintain gas, plumbing, dry air and RO water systems; perform sheet metal/duct work * Lead customer site installations * Develop and comply with all policies and work instructions * Maintain good housekeeping practices and participate in 5S activities * Perform as a member of the On-Call team * All other duties as assigned Requirements Education/Experience Requirements: * 10+ years of HVAC experience * EPA certificate * High School diploma, Military, Technical School or Associates Degree * Gain or maintain industry knowledge through training and seminars * 4+ years of ultra low refrigeration experience * Refrigeration license Additional Experience/Skills: * Electronic, electrical and mechanical skills * Good written and verbal communication skills * Strong reporting and documentation skills * Attention to detail and accuracy are essential * Good organizational skills * Computer literacy especially in Microsoft Windows, Word, Excel and Outlook * Solid knowledge of GMP/GLP and ISO 9001 * Soldering and brazing Physical Demands: * Ability to lift 75 lbs. * This position involves manual dexterity, bending, lifting, walking and standing for long periods of time * Work environment is typically general office, freezer rooms, mechanical areas, rooftop equipment * Drug testing * Inoculations may be required * Valid driver's license

Biorepository Inventory Coordinator

Masy Systems

Posted 5 months ago

VIEW JOBS Apply 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 150 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. Purpose: The Biorepository Inventory Coordinator is responsible for maintaining the accuracy and integrity of the data contained within the inventory database and ensuring continuous improvement goals for the system are met. Key Responsibilities: A. Oversee the maintenance of and access to the inventory database * Develop, oversee and improve the inventory database and associated processes. * Interface with vendor to ensure the inventory system meets Masy's requirements. * Create and modify Biorepository forms generated within the system. * Process new internal and external user requests while ensuring confidentiality requirements are met. * Communicate with customers to revise and improve their user interface. * Provide training, direction and guidance to other personnel with tasks associated with the inventory database. B. Maintain the accuracy and integrity of the data contained within the inventory database * Communicate with customers to ensure pertinent information is captured. * Enter and review product data in the inventory database. * Identify and reconcile inaccuracies during incoming shipment inventory processing. * Compile and submit the appropriate billing for hours applied against specific inventories. * Conducts physical inventories as needed to verify the accuracy of the database. * Compiles inventory reports based on customer request. * Conducts complete physical inventories upon customer request. C. Maintenance of operations and safety standards * Store product appropriately and enter information electronically into applicable system. * Manage temperature in chambers during addition and removal of product. * Follow Good Documentation Practices (GDPs) to ensure documentation is complete and accurate. * Foster Good Manufacturing Practices (GMPs) in writing/executing specific in-house procedures and work instructions. * Understand temperature and time as they relate to customer storage needs. * Effectively communicate important issues or potential problems to management. * Maintain current training in DOT and IATA hazardous materials regulations. * Manage long term projects. * Fill in for Biorepository Operations and Stability Support Manager when they are absent. * Other duties as required. Requirements Education/Experience Requirements: * AS or BS degree in a related field or equivalent experience required. * 2+ years of inventory control experience. Additional Experience/Skills: * GMP/GLP, ISO 9001 proficient. * Honesty, integrity, and confidentiality. * IATA and DOT trained shipper. * Strong organizational, interpersonal, written and verbal communication skills. * Strong time management and problem solving skills. * Ability to plan, organize and manage work initiatives. * Team player with a strong sense of responsibility and self-motivation. * Proficient with Windows Office suite and database management. * Detail oriented. Physical Demands: * Drug testing. * Inoculations may be required. * Work environment is typically general office and warehouse (ambient to -80C). * Able to lift 50 lbs.

Apply