Lead Documentation Specialist

Job Description

Job Description

Job Description-Lead Documentation Specialist

G&F Precision Molding Inc., Fiskdale, MA, is growing! We are agile, innovative, customer-centric, and our goal is to provide specialized, creative solutions and a commitment to ongoing service and quality. G&F Precision is unique; our core business is life science including medical devices and pharmaceuticals. We provide custom solutions to universal manufacturing needs. We have the experience, ability, and drive to tackle challenging projects from concept to execution.

Our work environment includes :

• Growth opportunities
• Safe work environment

We're seeking a dedicated Lead Documentation Specialist to join our team. The ideal candidate will be responsible for updating and formatting procedures and work instructions, maintaining training records, and processing document change orders (ECO). The Documentation Specialist will create and verify Certificates of Conformance and review and verify other documents supplied to the customer. Included duties with this position are the review, verification and filing of completed production work orders and documentation. This position includes management and control of MRB, along with special projects within the Quality Department under the Director of Quality’s supervision.

Job Type : Full-time Salary : $60,000-$80,000 / year

Essential Job Duties and Responsibilities :

Reviews verifies and files completed production orders and documentation

Requires approximately 80% computer work and 20% work on the production floor

Receives and complies with verbal and written directions

Performs all work in conformance with G&F quality management system

Complies with all G&F Safety Rules, Policies and Procedures

Performs additional duties and functions of a related nature as assigned without notice

Technical Requirements :

Experience with ISO 9001 or 13485, and cGMP preferred

Strong communication skills in English, both oral and written

Strong understanding of Microsoft applications (Word, Excel, Outlook)

Works well in group office environment

Able to respond to frequent change, delays, and unexpected events

Detailed oriented

Can work independently and within a team

The Lead Documentation Specialist reports to the Director of Quality.

Experience, Education and Training Requirements :

Authorized to work in the U.S.; eligible to work in the U.S. without sponsorship

High School Diploma or Equivalent

Able to deal with frequent changes, delays or unexpected events

Minimum of 2 years’ experience working in a professional office environment

Physical - Must be able to complete all requirements with or without reasonable accommodation

Wear full Personal Protective Equipment while in cleanroom environment

Must be able to lift as much as 15 pounds at times

Prolonged periods sitting at a desk and working on a computer

Visual acuity is required to read instructions

Benefits :

401(k)

401(k) matching

Dental insurance

Dependent care account

Employee assistance program

Flexible spending account

Health insurance

Health reimbursement account

Holidays (9)

Life insurance

Paid time off / Vacation

Parental leave

Professional development assistance

Tuition reimbursement

Vision insurance

Schedule :

Day shift, generally 8a-5p

Monday to Friday

Language :

English (Required)

Written (English Required)

Work Location and Mode :

At G&F Precision Molding, we value teamwork and collaboration. This role requires employees to be onsite, at one location, five days per week

This role may be required to travel to our other location in Danvers, MA infrequently

Ability to commute / relocate :

Fiskdale, 01518 : Reliably commute or planning to relocate before starting work (Required)

Relocation Assistance :

Relocation assistance is not available for this position at this time

Visa Sponsorship :

G&F Precision Molding will not offer sponsorship or take over sponsorship of an employment visa for this position at this time