Quality Associate I

This position is responsible for parts of the activities within Document Control and Training Requirements. The Quality Associate I, Training & Document Control will identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, as well as quality practices.

This position supports, monitors, and maintains the day-to-day training and record control processes within Operations & Quality. The position also involves working closely with various Supervisors at the facility to monitor and maintain a central computerized training database for all employees. Specific responsibilities may include, but are not limited to:

Documentation:

• Ensures efficient processing of document and change management systems for the Quality Management System.
• Supervises the functional activities and employees associated with the creation, revision, issuance, review, and storage of controlled quality records in compliance with GDPs. Ensures documents, forms, and records are accurate and complete.
• Ensures that records of changes to documents are maintained in accordance with regulatory requirements.
• Ensures documents of external origin (e.g., Regulations and Standards) are identified and evaluated for impact to the organization.
• Provides training, guidance, and coaching in the areas of responsibility for direct reports and internal and external customers.

Training:

• Manages and monitors training completion.
• Works with Managers and/or Lead Trainers to ensure training plans are developed for every job description and updated as necessary.
• Works with Human Resources to ensure Job Descriptions are written and updated as necessary.
• Manages and communicates training metrics.
• Works with managers to organize/schedule training events as needed.

III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

• Must have computer proficiency with solid experience in Microsoft Word, Excel, Adobe Acrobat, and other systems.
• Ability to work effectively as part of a cross-functional team.
• Ability to relate and work well with people.
• Excellent organizational and verbal/written communication skills.
• Attention to detail.

IV. EDUCATION/EXPERIENCE REQUIRED

• BS in business, science, or engineering required.
• 1 years of experience in Quality within a medical device/pharma or other regulated industry.
• Experience in development and maintenance of a training documentation database preferred.

Job Types: Full-time, Contract

Pay: $28.00 - $31.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 1 year (Required)
• Quality management: 1 year (Required)
• Medical documentation: 1 year (Required)

Location:

• Skaneateles Falls, NY 13153 (Preferred)

Ability to Commute:

• Skaneateles Falls, NY 13153 (Required)

Work Location: In person

Salary : $28 - $31