Department: Quality Assurance

Reports To: Manager of Quality Assurance/Systems

SUMMARY
Responsible for supporting product qualification, process validation, quality planning, Nonconformance/Corrective Action assessment and tracking, Complaint Handling, Technical Engineering Support for all Quality Assurance functions associated with the product(s) of this company. Revisions to current and proposed products/systems will be identified and assessed by the incumbent as required to ensure compliance to company policies and cGMP’s.

ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following, although other duties may be assigned.
• Responsible for Corrective and Preventive Action (CAPA) Program, NCMR System, Deviation System, Out of Tolerance, and Facility Incident Notices.
• Follow-up on completion of corrective actions to ensure timeliness and CAPA effectivity.
• Update databases; prepare metrics, present trending and tracking at Management Review Meetings.
• Review/Approve Validation Protocols and Reports (IQ, OQ, PQ), studies, etc. Review/Approve rework of Product.
• Conduct customer complaints investigation, including identifying root cause of the complaints, determine appropriate corrective and preventive actions, and trending.
• Work very closely with Customer Service, Process Development, and Manufacturing Engineering to resolve customer complaints, including performing statistical data analysis, trending and presenting data to management for action.
• Maintenance of Quality Systems to current regulations.
• Support FDA, FDB, Government inspections, and International Regulatory Inspections, preparations and corrective actions as needed.
• Assist in Internal Audits, recalls, and removals as needed.

We are an Equal Opportunity Employer.

Excellent Salary and Benefits.

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.
• Experience with FDA (or other regulatory) inspections.
• Experience in Aseptic Manufacturing.
• Hands-on SPC, design of experiments, risk management, FMEA (use design and process), statistical sampling techniques, process validation (IQ/OQ/PQ), test method validation, Gage R&R, etc.
• Proficiency with FDA regulations (QSRs), ISO 13485 required; knowledge of ICH guidelines preferred.
• Excellent written/oral communication skills, focused self-starter, attention to details, team-oriented but able to work independently and proactively, and ability to multitask.
• Working knowledge of MS Word, Excel, PowerPoint and Project.
• Working knowledge of an electronic document management System.
• Ability to travel (10%).

EDUCATION AND/OR EXPERIENCE
• Bachelor’s degree in Engineering, Quality, Science or Technical Discipline and a minimum of four-years of experience in a Quality Engineer Position in a GMP/QSR related industry.
• Strong knowledge of FDA Quality Systems Regulation, ISO, and other International Quality System Regulations.

LANGUAGE SKILLS
• 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 apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS
CQE, CQA highly desirable.

For immediate consideration, please forward a copy of your current resume to xxxxxx@xxxxxxxxxxxxxx.xxx referencing job #5872.

It is unlawful to employ a person who does not have permission to live and work in the USA. Unless the advert states otherwise, please ensure you have this permission before applying.