Lead Documentation Specialist

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

Were 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 Qualitys supervision.

Job Type: Full-time Salary: $60000-$80000/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