Quality Specialist

Integrated DNA Technologies

JOB DESCRIPTION

Quality Specialist

Employment Status: Non-Exempt

Group: Quality Assurance

Location: Coralville, Iowa; San Diego, CA;-Mobile (On-Site/Work from Home Hybrid)*

*Mobile associates must live in an area that does not exceed a 100-mile (150 km) radius of an IDT location.

Purpose statement:

The Quality Specialist is responsible for providing administration of key components of the Quality Management System.  This may include but is not limited to document control, audit, training or process control functions.  

Essential Functions:

  • Reports to the Manager of Quality Systems and is responsible for coordinating and maintaining key components of the Quality Management System

  • Maintains records and processes for document handling, audit, process controls (NCR/Deviation/CAPA) and training – may participate in several aspects.

  • Interacts professionally and efficiently with manufacturing and support staff: administrates /supports the intra-department functionality of the QMS with departments throughout IDT.

  • Prepares reports of quality system performance for internal departmental use, as well as management review.

  • Serves as a member of internal audit teams for execution of audits at the Coralville location, as needed.

  • Assists in developing content for and delivering training on various quality systems functions such as NCR’s, deviations, document control, training system administration, and validation activities.

  • Participates in customer and third-party audits, as needed.

  • Assists with the development and implementation of responses for customer, regulatory and certifying body audits, as needed. 

  • Performs other duties as assigned.

Education:

  • Bachelor’s degree in a related field or equivalent experience

Professional Experience:

  • Previous professional quality assurance experience in manufacturing industry preferred

  • Experience and familiarity with ISO:9000/13485 standards and FDA QSR/cGMP standards, strongly preferred

Other Job Qualifications

  • Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.

  • Statistical analysis, precision measurement, and process capability studies will become an intricate part of quality assurance programs; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices, may be essential for this position.

  • Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure.

  • Ability to maintain both a high standard of courtesy and cooperation in dealing with co-workers.

  • Ability to accept responsibility for the direction, control or planning of an activity.

  • Adaptability to situations requiring the precise attainment of set limits, tolerances or standards.

Physical Requirements:

Exert up to 10 lbs. of force occasionally and/or up to a minimal amount frequently

Visual Acuity:

  • Work requires close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.

  • Ability to read pertinent printed material and distinguish colors.

  • Ability to accurately read measurements on equipment.

  • Ability to prepare and read written documentation; use of computer.

What We Offer: 

  • Generous Paid Time Off Accruals

  • 16 Hours PAID Volunteer Time Off

  • 10 Paid Holidays

  • Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

  • 401(k) with Company Match

  • Medical, Dental, and Vision Insurance Options


Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Job ID: 73206

Posted 18 days ago

Share This Job