Summary
Coordinate and/or perform the day-to-day activities of Quality Systems such as complaint handling, supplier qualification, deviation management, change management and document control.
Assist in assuring that Spectrum operates in accordance with current Good Manufacturing Practices & regulations and in compliance with ISO 9001:2015 Quality standards.
Essential Duties And Responsibilities Include The Following As Assigned:
- Collaborate with various departments to ensure completion of deviation investigations, CAPAs, complaints, and change controls.
- Support Supplier Qualification Program.
- Assist as needed in Customer Quality System Audits, Internal Audits and / or Regulatory Inspections.
- Maintain Customer Change Control Program and Notification Support to affected parties.
- Assist with quality investigations.
Supervisory Responsibilities
This job has no supervisory responsibilities.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
- Experience working with current Good Manufacturing Practices 21 CFR 210 & 211 (required)
- Knowledge/experience in Quality System requirements of ISO 9001:2015, ,21CFR 11, IPEC and ICH Q7/A (preferred)
- Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker.
- Bachelor's degree(BA/BS) from four-year college or university (life sciences degree preferred).
- Lean process improvement and Six Sigma,5 S experience and background preferred
Language Skills
Must have strong oral and written communication skills and be able to manage multiple tasks. Ability to read, analyze and interpret common scientific and technical journals, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or members of senior management. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills
Ability to calculate proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability
Ability to apply commonsense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Certificates, Licenses, Registrations
None required for this position
Physical Demands
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to sit. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
