Quality Assurance Document Control Specialist

QA Document Specialist

The QA Document Specialist will be responsible for maintaining the ISO standards for document control process and ensuring information integrity in accordance with established ISO 9001:2015 procedures. The person in this role must fully understand the requirements for the product and have a sense of responsibility towards our potential and existing customers. The successful individual will be able to work with hourly manufacturing team members and department managers to ensure adherence and ownership of the quality program and provide outstanding value and commitment to the organization in the most cost-effective manner within quality standards.

Responsibilities

• Works with all departments to receive, prepare, route, and track document change requests. Implements approved changes and maintains complete and accurate document change request records.
• Creates, formats, edits, routes, finalizes, files, and maintains all controlled documents. Coordinates with Subject Matter Experts (SMEs) to ensure document accuracy.
• Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released.
• Ensures periodic document reviews are completed in a timely manner.
• Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finding innovative, well thought-out solutions to problems.
• Manages corrective action, preventive action, and change control systems including creation, assignment, monitoring, verification, closure, and metrics/trending for all formal corrective actions.
• Conducts or coordinates training as required for cGMP, documentation, corrective actions, and complaints.
• Supports customer and regulatory audits as required.
• Participates on assigned project or LEAN teams.
• Prepares and distributes approved change control notification in line with customer requirements, includes the review and approval of customer specifications
• Other duties as may be assigned

Skills & Qualifications

• Bachelor's degree in relevant field (e.g. Business Administration, Engineering, Data Analytics) is preferred. Consideration is given to Quality certifications and relevant experience
• Must have a minimum of 3-5 years of experience in production environment. Experience in ISO 9001, AS9100, or ISO 13485 is required.
• Experience in pharmaceutical, medical device, automotive, or other regulated industry is preferred.
• Experience in a lean manufacturing / six sigma environment is preferred
• Effective skills and ability with MS Office to create reports, spreadsheets, and presentations.
• Effective PC skills to learn and use ERP, SPC, Minitab, and other software as needed
• Must have excellent communication skills and be able to effectively work with others in a team environment.
• Must be able to read and interpret requirements, standards, drawings and specifications.
• Familiarity with all aspects of quality control/assurance techniques such as, corrective/preventative action plans, complaint handling, document control, and root cause investigations.
• Detail oriented with excellent time management and organization skills
• Highly compliance oriented to firmly adhere to principles of regulation and standards.

Qualifications

• Is knowledgeable of and follows applicable work instructions and current good manufacturing practices (cGMPs).
• Employee pays attention to detail. Employee completes paperwork accurately, neatly, and completely.
• Employee willingly works in different areas as assigned.
• Excellent time management skills and organization skills
• Ability to exercise good judgment in determining the reasonableness of actions.
• Ability to work with minimum supervision.
• Innovative with the ability to make sound suggestions for improvement.
• Highly compliance-oriented to firmly adhere to principles of regulation and standards.
• Must have excellent communication skills and be able to effectively work with others in a team environment.

Salary range of $55,000- $70,000 annually

More About Filtration Group

Filtration Group is on a mission to make the world safer, healthier and more productive. With a passionate workforce, global footprint and world class engineering and manufacturing capabilities, we are driving innovation and developing solutions across a broad spectrum of applications in the fast-growing and rapidly-evolving global filtration industry. We are committed to maintaining an entrepreneurial culture built on a foundation of trust and in which our leaders exhibit a strong bias for action.

The Company began in 2009 and has rapidly grown organically and through a thoughtful acquisition strategy to be a global leader in the highly attractive filtration industry. Filtration Group has the broadest portfolio of solutions in the industry and has had a particular focus on building a leading platform of solutions focused on the Life Sciences and Indoor Air Quality end markets which are rapidly growing in the current market environment. Filtration Group produces mission critical products with high replacement rates. Over 80 percent of the Company's revenue comes from replacement / consumable products, many of which are specified into customer's products or processes. With revenues over $2 billion, Filtration Group is consistently recognized as the fastest growing and one of the largest filtration businesses in the world and has a global footprint of 141 facilities in 28 countries. Filtration Group has over 10,000 employees who are united in their Mission to make the world safer, healthier and more productive.