Quality Specialist II Doc Contro

Creative Solutions Services, LLC; Campbell (CA); On-site; USD 83,000 - 91,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

Job summary

Creative Solutions Services, LLC is seeking a document control professional to support the Quality Management System and regulatory compliance. You will manage document changes, train staff, and assist in audits while maintaining batch records and supplier documentation.

Ideal candidates have a technical writing ability, MS Office proficiency, and prior document control experience in a medical device environment. This is an on-site role in Campbell, CA with a 3-month assignment and daytime hours.

Qualifications

• Bachelor’s degree in related field and 1 year of work experience or an equivalent combination.
• Experience with quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001).
• Excellent written and verbal communication skills.
• Ability to review documents with thorough and meticulous attention to detail.
• Strong multi-tasking, organized work style and proficiency in MS Office.

Responsibilities

• Support the Quality Management System and regulatory compliance documentation.
• Identify gaps and revise forms, work instructions and procedures.
• Assist in investigations and CAPA activities with root-cause analysis.
• Provide support during audits and maintain quality metrics.
• Maintain approved supplier lists and track supplier qualifications.
• Review batch records and change orders for accuracy and completeness.
• Manage document control training planning and training administration.
• Promote the Quality Policy and ensure GMP/FDA compliance.

Skills

Detail oriented

MS Word

Excel

Cross-functional communication

Technical writing

Education

Bachelor’s degree in related field

Tools

Electronic QMS

Job description

Pay $40.00 - $42.00
3 month + assignment (coverage for a leave)
Hours: 8am to 5pm
100% onsite in Campbell, CA

Ideal candidate

• Is detail oriented.
• Is comfortable navigating in an electronic QMS and is very comfortable with Microsoft word (formatting, table of contents, and redlines), as well as excel (formatting, comments).
• Is comfortable talking with/interacting with cross-functional individuals from a variety of departments and levels (ex: Marketing, Quality, R&D, Ops) through email, IM, or Phone.
• Has a decent level of technical writing ability and can clearly communicate via email.
• Can be 100% on-site Monday-Friday 8-5pm.
• Has previous experience in document control at a medical device company.

SUMMARY

As a developing professional, this position works directly with multiple cross-functional teams to provide support and maintain the Quality System in compliance with requirements of internal procedures, and applicable regulatory requirements. This role will record, review, product release, and share knowledge of document control.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support company policies and procedures to ensure the Quality Management System and regulatory compliance requirements are entered, maintained and monitored.
• Identify gaps, enhancements and revise/improve forms, work instructions, and procedures to maintain quality compliance.
• May assist in conducting investigations and root cause analyses and provide recommendations for corrective and preventive action plans for identified issues.
• Provide support during internal and external audits.
• Assist/maintain quality metric reports, as defined by management.
• Assist in updating the Approved Supplier List based on the results of the supplier evaluation form.
• Assist in the maintenance of the approved supplier list and supplier files, including updating of supplier certifications and coordination of requalification activities.
• Review batch records to support release of raw materials, subassemblies, and final products. File and maintain batch records current.
• Review proposed document changes, coordinate with change initiators/reviewers to address redlines and feedback, review change orders for accuracy and completeness.
• Collect and provide trending data on document processing metrics.
• Responsible for the administration activities related to document control system.
• Maintain and implement electronic and hard copy logs tracking externally referenced documents and standards and tracking the locations of controlled documents.
• File and maintain quality system documents/records, archiving and tracking the locations of all controlled documents/records, including off-site document storage.
• Ensure change initiators/reviewers have identified the appropriate training criteria for applicable employees to controlled documents and ensuring that the initiators/reviewers train these employees in a timely manner following approval of a change.
• Assist in the generation and maintenance of training plans, notification of training timeliness reports, assignment of training plans to on boarding employees, and all the administration activities related to training system.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements.
• Actively promote and support the company’s Management Review process.
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.
• Other duties as assigned.

EDUCATION / EXPERIENCE

• Bachelor’s degree in related field and a minimum of 1 years of work experience; or equivalent combination of education and work experience.
• Working knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), and good manufacturing practices.
• Excellent communications skills (both written and verbal).
• Ability to provide thorough and meticulous review of documents.
• Ability to perform multiple tasks concurrently timely with accuracy and organized.
• Proficient in Microsoft Office products.

Benefits (employee contribution)

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

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