Quality Document System contract

Title : Quality Document System, Contractor

Duration : 12 months Contract

Location : San Diego -CA

Pay Rate : $45/hr on W2

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Document Control Support

o Facilitate timely processing of new documents, document changes and change controls.

o Reviews internal documents prior to issuance to confirm compliance with Client standards and works with document owners to resolve deficiencies.

o Supports the periodic document review process to ensure timely completion of reviews.

• Complaint Handling Support

o Supports entry of product complaint reports into eQMS.

o Supports eQMS training program (Master Control/Compliance Wire) to ensure training is deployed to appropriate personnel.

• Records Management Support

o Supports QMS record storage, including organization and retrieval of records stored at the San Diego facility. Participates in the review of retained records for transfer to off-site storage locations or disposal as required.

• Supports audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.

• Provides input to support the continual improvement of document control, record management, and training administration processes.

• Performs duties in accordance with the Company’s QMS and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum two years of college or work experience equivalent.

• 3 or more years in medical device or pharmaceutical document management, change control management, and training administration systems.

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.

• Experience with eQMS software for document and record management and training administration. Knowledge of Compliance Wire and/or Master Control a plus.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

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.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process.

Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) ###-####, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.

Tagged as: Engineering