Documentation Analyst ; Aesthetics Med Device; Bothell WA

Documentation Analyst I (Aesthetics Med Device) (Bothell WA)

Job Description Job Alerts Link Apply now Documentation Analyst I (Aesthetics Med Device) (Bothell WA)

Job Location:

Bothell, Washington, USA Job Requisition

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

Position Title:

Documentation Analyst

FLSA Status:
Non-Exempt

Reports To:

Supervisor, Documentation

Note:

The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

• Administer the Agile Change Order, Manufacturing Change Order, and Deviation processes, including initiation, checking, routing, releasing, implementing, and final review
• Coordinate with other disciplines to ensure change orders are complete and meet documentation requirements prior to routing
• Coordinate with other disciplines to ensure change order implementation actions are complete; monitor and report on action status
• Lead change review meetings
• Assist other disciplines with Agile tasks
• Maintain physical document control records (e.g., DHRs), including performing reviews, sorting, filing, packing, and assisting others in retrieval
• Perform administrative Agile tasks such as user management, generation of monthly metrics, and supporting quality audits
• Ensure that documentation complies with GMP and regulatory requirements
• Assist in development of new and revision of existing Agile processes
• Additional duties as defined by supervisor

• Proficient in the use of PC software (MS Word, Excel, etc.)
• Effective verbal and written communication and interpersonal skills.
• A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
• Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
• Familiarity with FDA QSR and ISO 13485 principles, especially those regarding documentation, change control, and configuration management, a plus
• Experience with Agile or other PLM systems a plus
• Experience working in a regulated environment a plus

• Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures.
• Ability to write procedures, reports, and business correspondence in English.
• Ability to effectively present information and respond to questions from groups of managers, and internal customers.
• Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to read regulatory, technical and clinical literature and documents and extract important concepts.

• May be required to perform lifting tasks of up to 20 pounds for short durations.
• Duties of this job may involve sitting for extended periods of time.
• Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.

Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.