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

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 doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

Position Title: Documentation Analyst

FLSA Status: Non-Exempt

Reports To: Supervisor Documentation

Principal Responsibilities and Duties:

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

Experience Education Training Skills Traits:

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

Language and Verbal Skills

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.

Math Skills

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

Analytical and Reading Skills

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.

Physical Requirements

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.

Work Environment

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

Safety

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.

The range of starting base pay for this role is $25-34 per hour. Actual starting pay will be based on a wide range of factors including but not limited to relevant skills experience qualifications and addition to base pay this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

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.