Senior Quality Systems Specialist

PURPOSE: Ensure compliance to external, FDA, ISO, MDD, CMDR, and internal Quality Standards and procedures for product development and manufacturing. Provide support and participate in all quality system investigations as needed, and other duties as assigned.

• Responsible for managing the complaint handling process including database maintenance, investigating complaints, coordinating, and resolving complaints in a timely manner and reporting on complaint metrics;
• Lead/participate in Quality Event investigations, and maintain Quality Event system;
• Write, revise, and train on standard operating procedures for continuous improvement;
• Support Quality System Compliance by performing internal audits of the Quality System as assigned;
• Perform supplier audits as assigned;
• Lead investigation, corrective/preventive action and implementation of Quality Management System process improvements;
• Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the quality department;
• Responsible for investigating and coordinating other quality system assignments (CAPA’s, NCR’s, audit findings etc.) in a timely manner;
• Managing customer , distributor, and internal requests for quality information (i.e. paper audits, general information);
• Manage effectivity/follow up program to ensure that CAPA’s and other QMS changes/updates are effective;
• Participate with FDA, ISO, internal, customer and supplier audits;
• Other duties as assigned, which may include, but are not limited to:
  • Department trending for reporting;
  • Assist in supporting the Annual Product Review program to meet company deadlines;
  • Coordinate Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas;
  • Perform training on Quality topics as outlined in yearly training schedule;
  • Ensure non-conforming material is handled when found, per the Non-conforming Material procedure;
  • Quality Assurance review of quality records;

• Strong working knowledge of 21 CFR 820, 210, 211, 600, ISO 9001:2008, and ISO 13485.
• High attention to detail and excellent organizational skills.
• Able to work in a fast paced team environment.
• High degree of critical thinking skills
• Excellent oral and written communication skills.
• Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint, and Access.
• Ability to work with others and teams to resolve quality issues and ability to work independently without supervision

• Bachelor’s degree in life science and 5 years of experience in the biotechnology or pharmaceutical industry or an equivalent combination of education and experience required.

GENERAL COMPETENCIES:

• Adapts to change, open to new ideas and responsibilities.
• Communicates well (written and verbal), delivers presentations, has good listening skills.
• Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slidepresentation (PowerPoint). The level of proficiency is defined by the requirements of the position held.

• Good listener, committed to finding solutions to problems, works well with difficult people.
• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers.
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions.
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
• Honest, accountable, maintains confidentiality.
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback.
• Information organized and accessible, maintains efficient work space, manages time well.
• Strives to understand contributing factors, works to resolve complex situations.
• Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices.
• Manages workload, works efficiently, and meets goals and objectives.
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements.
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner.
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity.

PHYSICAL REQUIREMENTS:

Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs, 1-33% of the time. Carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to toxic or caustic chemicals.

BENEFITS:

• 401(k)/ with a company match up to 6%
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance