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 location.  In 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.