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Quality Management Systems Technician

job details:

• location:Big Flats, NY

• salary:$15.72 - $24.93 per hour

• date posted:Wednesday, January 13, 2021

• job type:Contract

• industry:Information

• reference:815448

job description

Quality Management Systems Technician

job summary:

A Quality Management Systems Technician is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Big Flats, NY area. This job is responsible for day-to-day activities related to Quality Management System database entry and tracking. Responsible for quality system projects, audit readiness activities, improvements or initiatives. Responsible for creating and updating documents in a standardized format to clearly communicate complex and technical information to end users. Responsible for managing quality documentation while ensuring accuracy, quality and integrity.

location: Big Flats, New York

job type: Contract

salary: $15.72 - 24.93 per hour

work hours: 8am to 5pm

education: Associates

responsibilities:

• Extract technical information from subject matter expert(s) and clearly document the information in procedure format

• Create and submit quality department change controls

• Review and update information in the electronic document management system

• Provide quality system database (e.g. EtQ, SharePoint, Box) day-to-day and test script support

• Track, review, process, scan and securely file quality system paper-based and electronic documentation (change controls, CAPAs, experiments, reports, RCIs, SCARs, validations)

• Review documents for accuracy and good documentation practices (GDP)

• Maintain department metrics for use in identifying continuous improvement initiatives

• Assign unique identification numbers to applicable documentation

• Document action items and attendance during Change Review Board, CAPA Review Board and RCI meetings

• Track CAPA and Change Control action items to closure

• Participate in audits (internal and external) and support follow-up activities

• Provide change control and training compliance back-up support as needed

• Support validation activities as needed

• Perform additional duties as assigned by supervisor

Preferred Education:

• Minimum 2-year Associates degree

Required Years of Experience:

• 1+ years of experience in a quality system, technical writing and/or information technology-related role; experience with cGMP industry standards and compliance is desired

Required Skills:

• Able to handle complex tasks, work independently with strong time management and prioritization skills to handle multiple assignments and interact with cross-functional project teams.

• Understanding of quality principles, practices and procedures to meet cGMP compliance

• Intermediate to advanced knowledge of Microsoft Office (Word, Excel, Outlook) and software applications

• Working knowledge of databases

• Able to read, understand and adhere to documented procedures

• Must be detail oriented and accurate with data entry

• Ability to disambiguate

Desired Experience /Qualifications /Skills:

• Experience working in an ISO and/or regulated industry environment

• Change control, CAPA, compliance system experience

• Experience working in pharmaceutical, medical device or automotive industries

Soft Skills:

• strong written and verbal communication skills

• Attention to detail

• Organized with good planning and time management skills

• Ability to build relationships within cross functional groups; team building skills

• Positive attitude, flexible and good work ethic

• Results oriented and high commitment

#LI-CM1

qualifications:

• Experience level: Experienced

• Minimum 1 year of experience

• Education: Associates

skills:

• Quality

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.