Validation Analyst 1

Quality Systems Engineer I (NC-CAPA)

Responsibilities:

• Under close supervision utilizes established procedures to perform routine assigned tasks and applies company policies and procedures to participate in the development review and improvement of the facilitys Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other facilities.
• Utilizes current acceptable industry/FDA requirements to justify write and implement process validation and GMP procedures. Drafts reviews and/or assists in the implementation of validation protocols final validation reports Quality System procedures performance qualifications and Engineering Change Orders (ECO). Maintains validation records and systems to keep ongoing process validations current and applicable to process.
• Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate when appropriate from current corporate documents.
• Analyzes processes work operations quality records complaints and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified.
• Investigates and assists in making recommendations necessary to correct and prevent recurrence.
• Uses appropriate statistical methodology such as CpK and trend analysis to assist in analyzing or reviewing manufacturing quality and/or laboratory data for recurring problems or the detection of negative trend. Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality. When recurring problems and/or negative trends are identified recommends corrective action for problem resolution.
• Reviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements.
• Participates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test and that all calibration activities are performed when due.
• Participates as a member of the facilitys Audit Team in performing internal and external audits as required.
• Assists in providing in-house training (e.g. calibration validations batch production and operation of equipment) in conjunction with plant management to operators and other personnel as assigned.
• Participates in product design control activities for new product lines.
• Conducts risk analysis (Fault Tree FMEA FMECA HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.
• Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production stocking or shipping of discrepant assemblies or product arises.

Qualifications:

• Bachelors Degree required preferably in Engineering Science Chemistry or Biology. An associate degree may be considered with additional years or relevant work experience.
• 0 - 2 years of combined Quality Engineering process validation required. Pharmaceutical manufacturing medical device manufacturing and/or laboratory (organic chemistry analytical and/or microbiology) experience preferred. With a masters degree no prior work experience may be necessary.
• Bilingual (English/Spanish).
• Knowledge of process validation (IQ OQ PQ) analytical instrumentation FDA regulatory requirements (GLP/CMP/QSR) Risk Management / HACCP concepts statistical process control and statistical problem solving. Also as applicable strong knowledge of Health Canada GMPs.
• Professional auditing certification (ASQ CQA RAB or equivalent) preferred for audit responsibilities.
• FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science certifications (i.e. ASQ CQE CMQ/OE) desired.
• Good verbal and written communication skills to make oral presentations and write technical reports.
• Must have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills. Knowledge of analytical laboratory methodologies is important.
• Good verbal and written communication skills to make oral presentations and write technical reports.
• Excellent interpersonal skills. Strong verbal and written communication skills.
• Must have good analytical skills.
• Knowledge of Microsoft Office. Create clear and short reports.
• Strong organization skills: ability to prioritize attention to detail.
• Ability to work with limited supervision. Ability to make sound independent decisions.
• Availability to work in any work schedule (Day night or weekends)
• U.S.A Visa required.
• Availability to travel to the U.S. and other country if required.