Quality Assurance Specialist Position Available In Barnstable, Massachusetts

Quality Assurance Specialist 2.9 2.9 out of 5 stars 124 Bernard St Jean Dr, East Falmouth, MA 02536

PURPOSE:

Ensure that the Quality Management System is compliant to

ISO 13485, 21 CFR

820, other applicable standards/regulations and internal procedures.

GENERAL RESPONSIBILITIES

Review and release of batch history paperwork prior to product release to ensure all requirements are met within the required timeframe to support ACC business needs; Review and release of kit requisitions; Investigate, coordinate, and resolve Quality System Events in a timely manner as needed; Participate in maintaining quality system databases and processes; Responsible for generating metrics reports for trending and reporting mistake free paperwork for all departments; Participate in Quality Improvement Teams as a representative of the Quality Assurance department; Write, revise, and train on Standard Operating Procedures; Perform CAPA and audit finding related activities as needed, including effectivity checks and follow up; Quality Assurance review of quality records, reports, and data (Contract Test Service reports, Quality Control data, instrument calibration reports, certificates, etc.); Quality Assurance review of other quality records; Performing receipt and release activities as needed (includes inspection and/or release of materials, including instruments, in the ERP system); Support QA inspection team as needed; Participate in year-end inventory activities, as needed. Conduct Quality Records Practices training for employees as required. Perform internal quality system audits, or support the process, as needed; Perform Supplier quality system audits, or support the process, as needed; Complete Supplier Quality questionnaires; Provide support for and/or lead on-site customer audits, including the processing of audit findings and follow up; Participate in or support FDA and ISO audits as required; Other projects and duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS

Strong working knowledge of 21 CFR 820, GMP, ISO 13485 Detail oriented and excellent organizational skills Ability to work in fast paced team environment Ability to work on multiple tasks and meet deadlines Excellent oral and written communication skills Proficiency in all office based software Use of Microsoft Excel (graphing techniques) and Word (formatting, spelling, creating tables). Excellent computer skills.

EDUCATION AND EXPERIENCE

A minimum of a Bachelor’s degree or an equivalent combination of experience and/or education required. A minimum of 2 years’ experience in an FDA regulated industry, biotech or other related industry or equivalent experience. Experience with audits preferable.

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 slide presentation (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) 401(k) matching 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