We are looking for a QA Documentation Associate who is highly motivated in seeking hands-on technical experience in medical device company. The position has the responsibility for supporting company’s quality system and assisting in project management under the direct supervision of Manager of Quality Assurance & Regulatory Affairs. This is an ideal opportunity to see all or part of the manufacturing quality cycle. Activities will include but are not limited to word processing of documents, and maintaining GMP records in the QA Archive and/or Arena Solutions. The candidate must be willing to work among a diverse, creative and talented team of biotech professionals.

· Support GMP Document Control department.

· Exhibit a passion for product development and product quality.

· Assist in preparation of Quality Documents and Medical Device History Files.

· Support the life-cycle of documents (creation, distribution, revision, review and implementation).

· Review documents for accuracy and adherence to formatting requirements.

· Assist in scanning and filing training materials, maintaining product files, organizing supplier management records.

· Help in performing Batch Record Review.

· Support track of Non-Conforming Product.

· Communicate with teams on status, issues and timings.

· Perform other tasks as assigned.

· Minimum of Bachelor’s Degree in life sciences with 0-6 months of experience with IVD or Medical Device products is a plus.

· Organized, flexible, and innovative team player.

· Working knowledge of ISO 13485.

· Ability to work in a fast-paced, constantly changing work environment.

· Strong organizational skills.

· Competent using MS Word and MS Excel.

· Skilled in oral and written communication.

Must be able to work on-site.

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Hayward, CA 94545 (Required)

Ability to Relocate:

• Hayward, CA 94545: Relocate before starting work (Required)

Work Location: In person