Document Specialist II

Title: Document Specialist II
Location: Carlsbad, CA 92008
Duration: Contractual
Pay rate: $22/hr. on W2

Job Summary:

This role receives, reviews, categorizes, scans, files, and tracks documents using specific classification and organization systems.

Responsibilities:

• The Document Control Specialist receives reviews and classifies incoming quality systems records and supporting materials such as Validations, Batch Records, Lab Notebooks etc.
• Creates files, labels and barcodes incoming records and prepares them for storage based on the company’s record retention policy.
• Manages verbal and written requests for records. Locates, retrieve, deliver and follow up on checked out records as requested.
• Performs technical and clerical assignments involving data entry, proofing and other administrative duties.
• Assists in the documentation of key processes and departmental procedures.
• Work on continuous improvement projects as assigned by management.
• Delivers training and Assists in the supervision of junior personnel.
• Demonstrates a sense of urgency and timeliness for assuring optimal record management.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
• Carries out duties in compliance with established business policies.
• Other duties as assigned, according to the changing needs of the business.

Qualifications:

• Two-year experience in records management and/or administrative environment
• Intermediate knowledge of MS Office
• High school degree
• Working knowledge of QSRs and regulations applicable to FDA and comparable regulatory agencies.

NOTE: Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

Contract length: 6 months

Job Types: Full-time, Contract

Pay: $20.00 - $22.00 per hour

Schedule:

• 8 hour shift

Education:

• High school or equivalent (Preferred)

Experience:

• records management and/or administrative: 2 years (Preferred)
• QSRs and regulations applicable to FDA: 1 year (Preferred)

Work Remotely:

• No

Speak with the employer
91 858.216.4342