Quality Assurance Representative

Salary Range: $48,000.00 To $53,000.00 Annually Department: Quality SUMMARY: The QA Representative (QA Rep) is the front line of quality for site operations. The QA Rep is involved in daily operations and decision making, working with the area operational staff to assure that operations comply with local standards, and products/services meet established quality criteria. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Additional responsibilities may be assigned. Compliance Monitor daily operations activities, communicate, and elevate issues appropriately Provide operations with product disposition, line clearance, and any other actions needed to facilitate daily production Conduct quality risk assessments of systems and controls Check for adherence to written procedures through self-inspections and assessments Periodic review of GMP-related data in the area Develop, implement, monitor and modify Quality action items Determine deviation level, ensure that investigations are complete, and that corrective and preventative actions are implemented Provide review and approval of required quality documentation (e.g., deviations, change controls, validation/qualifications packages, area or equipment operation procedures, and drawings) Conduct internal audits Participate in vendor, third party and GMP service provider audits Evaluate process excursions for potential impact to product SISPQ Write procedures, investigations, customer correspondence, and any other quality functions that require documentation May be required to complete customer specific in-process sampling Business Partnership Participate on process or area teams Align area Quality Plan action items with business objectives Work collaboratively with customer quality units to resolve problems and develop opportunities Technical Excellence Understand the impact of quality processes on production/productivity Participate on teams, committees or groups to achieve departmental, site or company goals Attend industry or professional organization meetings Maintain sound technical understanding of the area’s processes MISCELLANEOUS DUTIES As assigned by upper management. The ability and flexibility to travel to multiple facilities within Plainfield is required. SUPERVISORY RESPONSIBILITIES The QA Rep has no direct reports, but must have the confidence and courage to enforce operational discipline and assure compliance. QUALIFICATIONS To perform this job successfully, and 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. Some college preferred. EDUCATION and/or EXPERIENCE High School Diploma or GED Equivalent required. One year of experience in a quality function, or 2 years experience in a quality systems environment, preferably in the pharmaceutical or supporting industries. Must be very detailed oriented. Proficiency with Microsoft® Outlook, Word, Excel, and familiarity with warehouse management systems. LANGUAGE SKILLS Ability to read, write, and interpret documents such as safety rules, operating and maintenance instructions, and correspondence. Ability to express concepts and thoughts in writing. Ability to respond to common inquiries or complaints form customers, regulatory agencies, or members of the business community. Ability to conduct training. Ability to speak effectively in front of groups, before customers or correspond via email. MATHEMATICAL SKILLS Ability to physically count, add, subtract, multiply and divide. Understanding of fundamental statistics. REASONING ABILILTY Ability to define problems establishes facts and draw valid conclusions. Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form. 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 sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is frequently required to stand, walk and reach with hands and arms. Must be able to discern color. 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 moderate. #J-18808-Ljbffr