Quality assurance specialist

Overview

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POSITION SUMMARY :

The Quality Assurance Specialist (eQMS and Document Management) is responsible for serving as one of the administrators of Knipper’s electronic quality management software (e-QMS) system and back-up to the supervising CAPA Manager;

independently supporting investigations, CAPA implementation and Effectiveness Check plans as well as Change Control. The QA Specialist will support all business units through direct support of the eQMS License Holders.

This will include entry of records, monitoring work-flow, editing and closing records. The QA Specialist will provide reports to Management, as requested.

100% onsite role based out of Lakewood, NJ or Charlestown, IN location.

Responsibilities

KEY RESPONSIBILITIES :

• Train eQMS License Holders on the proper use of the system following Train-the-Trainer .
• Train non-License Holders on the proper use and submission of eQMS Templates
• Support the performance of Quality investigations, CAPA, Effectiveness Checks and Change Control in support of all business units and maintain all eQMS records in a consistent compliant and timely manner.
• Collaborate with each business unit to resolve incidents and Quality Events using business communications, trending, root cause analysis, and corrective / preventive action activities to allow the business to improve product and process quality.
• Support the management and implementation of the Document Management system including the creation, revision and retirement of documents for all business units.
• Influence without authority and work across organizational boundaries.
• Exhibit strong collaboration and team building skills.
• Execute document controls and management of changes.
• Distribution of new controlled documents, procedures, and instructions.

The above duties are meant to be representative of the position and not all-inclusive.

Qualifications

MINIMUM JOB REQUIREMENTS :

• Bachelor’s Degree
• Ability to work independently and in a team environment
• Very good communication and writing skills and customer service
• Ability to prioritize multiple tasks and accomplish them in a timely manner

KNOWLEDGE, SKILLS & ABILITIES :

Proficient in Microsoft Office applications. WORD Level basic skills required; EXCEL Intermediate Level required. Ability to learn internal software programs including eQMS / TrackWise Digital, Share-Point, and TimeTrak,Ability to maintain the highest level of confidentiality.

Knowledge of Quality Assurance Systems, cGMP and Good Documentation Practices preferred.Strong knowledge of cGMP and Good Documentation Practices

Ability to use a calculator to perform basic math functions and understands the concept of same including : add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals;

compute ratio, rate and percent.

PHYSICAL DEMANDS :

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an equal opportunity employer.

Last updated : 2024-03-22