Quality Compliance Specialist / Compliance Training Specialist (Pharma/Healthcare)

100% onsite (no remote) at Scarborough location M-F 8a-5p EST, hours flexible

Not looking for training Specialist or instructional designers or teachers QA or quality compliance individuals are more successful in this role

Work with FDA compliance

QA Auditor will also be a good fit for this role Mon - Fri role Onsite role 100% ANy Data entry background individual will work Agile or oracle systems exp will be given preference

• Looking for compliance exp
• High school with 5 - 6 yrs exp needed
• Compliance training and compliance data entry of training data
• LMS systems: Agile or oracle exp will be wonderful
• LMS assignments but no training work
• Easy to learn and comfortable with data entry
• Mostly data entry work (repetitive work)
• Not looking for teachers or instructional designer as they will not be training anyone
• History of using multiple electronic systems
• High School or associates degree will work if candidates has experience
• Not Looking for sales candidates
• Will be working in Agile (Quality system) and metro (LMS system)

Top skills

• Compliance
• LMS (Agile, oracle)
• Any audit related exp
• Regulated environment exp

6 month assignment with potential option to extend. **Preference given to local candidates and those who can start within 2 weeks of job offer.

Description

• The position of Quality Training Compliance Specialist is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.
• This role provides training support and expertise to employees to ensure continued compliance with Quality System and administration of the divisional Learning Management System.
• The Quality Training Compliance Specialist is responsible for the maintenance of the Learning Management System, training reporting, and records.
• This job description will be reviewed periodically and is subject to change by management.

Responsibilities:

Supports the administration of the Learning Management System (LMS) and management for the Quality System Training Program to ensure employees are trained to perform their activities.

• Provides Subject Matter Expertise on the learning process including learning management system to other functional areas.
• Ensures effective communication, monitoring and promotion of learning activities.
• Liaises with Division, Managers and Team Leaders to continuously improve learning processes and/or systems.
• Establishes and maintains a direct and proactive relationship with internal and external customers, has a strong understanding of current customer needs, anticipates and addresses issues, escalating as applicable.
• Authors and reviews learning documentation/material.
• Supports audit readiness to ensure successful audit inspection results related to the Learning system and/or processes.
• Ensures training program meets quality standards.
• Coordinate and support completion of training programs that are required to meet cGMP requirements.
• Maintains applicable administrative procedures and policies to ensure compliance with business process and regulatory expectations.
• Conduct training curriculum reviews and revise training plans accordingly
• Create and assist with the development of training materials.
• Coordinating resources (other presenters/instructors, course materials, training space, etc.),
• Create/manage a qualified train the trainer program

Basic qualifications | education:

• BS in preferably in Education, Science Engineering, Human Resources, Business, Instructional Design, or related discipline or equivalent combination of education and experience.
• 2-5 years experience in the medical device or regulated industry preferred.
• Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel

Preferred qualifications:

• Familiar with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR
• Knowledge of adult learning delivery techniques and general principles of adult learning a plus.
• Ability to think strategically and provide direction to the management team along with the capacity to balance both short term and long term issues effectively.
• Preparing and delivering presentations
• Requires strong written and verbal communication skills.
• Requires strong organizational and time management skills, and the ability to prioritize multiple responsibilities and projects.
• Requires ability to deal appropriately with regulatory agencies.
• Requires working knowledge of training requirements required by regulatory agencies (documentation, effectivity, etc.)
• Must be able to work independently under minimal supervision.
• Must follow standard safety policies and procedures.
• Experience utilizing word processing software (e.g. Microsoft Office - Word, Excel and PowerPoint)

An equal opportunity employer, Client welcomes and encourages diversity in our workforce.

• We provide reasonable accommodation to qualified individuals with disabilities.

Job Type: Contract

Pay: $30.00 - $32.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• QA Audit or quality compliance: 2 years (Preferred)
• LMS (Learning management systems): 2 years (Preferred)
• Agile or oracle systems: 2 years (Preferred)
• Pharma or healthcare industry: 2 years (Preferred)
• Data entry of compliance data: 2 years (Preferred)

Ability to Commute:

• Scarborough, ME 04074 (Required)

Work Location: In person

Salary : $30 - $32