Works independently under close supervision, work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. Responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. Interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Develop and execute test plans to ensure that all objectives are met.
Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. Identify and remedy defects within the production process.

Why Avantor?

• Full-Time Health Benefits on Your First Day
• Competitive Time off Package (PTO and Holidays)
• Employee Stock Options
• Retirement Plan Options with company match
• Direct Hire

What does the position do?

• Responsible for the continual improvement of the Quality Management System.
• Responsible for Batch Record Review and Batch Release.
• Establishes, coordinates, and monitors the Quality Management System.
• Works closely with managers and supervisors to plan, schedule and implement QA related activities.
• Prepares routine and special reports to staff, and regulatory agencies as required.
• Implement correction action in processes as the need arises. Reviews and approves report of analytical results/Certificate of Analysis for compliance evaluation.
• Create and develops or approves standard operating procedures.
• Serve as document owner responsible for document creation (SOP, Work Instructions, etc), maintenance, and compliance for processes where QA Specialist is knowledgeable.
• Prepares and/or maintains computer programs for the compiling and statistical analysis of quality assurance data.
• Develops and presents training program as GMP and GDP for Avantor.
• Develops and performs internal audits program. Identifies and generates corrective action plans, provide follow ups and communicate results to management.
• In charge of the internal and external audits. Answers customer and suppliers audits completely and timely.
• Collect, analyze, and document objective evidence as the need arises in the assigned audits.
• Determine whether or not procedures, documents or other information describing or supporting the quality systems are known, available and dues by associates.
• Evaluates quality events, investigations, discrepancies, noncompliance issues (SCAR’S), corrective and preventive actions reports and possible complaints.
• Identify correction actions in procedures and processes.
• Manages and maintains databases for the quality system and prepares a quality trending reports.
• Participate in quality and planning meetings and applicable Corrective Action Team activities.
• Develops and implements a coordinated applied program quality assurance; writes clear and concise reports; works with a variety of managers and supervisors to plan, schedule, organize and coordinate the quality assurance program.
• Performs standard quality assurance/quality control evaluation procedures, evaluating data using statistical methods for analysis, interpreting results of analysis, and making appropriate recommendations to management in developing and presenting a variety of training programs and preparing manuals and documentation.
• Interacts with associates, clients and suppliers.
• Must be affable and warm maintaining and guarding for an atmosphere of collaboration, teamwork and respect even in moments of stress.
• Complete audit paperwork as defined and required.
• Performs other duties as assigned.

What do you need to have?

• Bachelor’s degree in science, chemistry or engineering strongly preferred
• Two to Four years’ experience the pharmaceutical or manufacturing industry

What would be nice to have?

• Knowledge in GMP, GLP, GDP and ISO regulations
• Experience creating, maintaining and auditing quality program
• Certified in Quality Program, preferable
• Microsoft office (Excel) skills, intermediate level
• Bilingual (Spanish and English), a plus

What’s the environment like?

• The work environment characteristics and physical effort described here are representative of those an associate encounter while performing the essential functions of this job.
• While performing the duties of this job, the associate is exposed to an industrial warehouse environment. The associate works near moving mechanical machinery and moderate noise level.
• The job requires working in heights, exposure to changes in temperature, driving equipment, and maybe exposed to dust, fumes, or gases.
• Physical effort is required. Work require walking, standing, bending, reaching, lifting or carrying objects that typically weigh more than 25 lbs.
• Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.
• Personal protective equipment required (safety shoes, respirators, gloves, safety glasses and laboratory coats required.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Avantor is proud to be an equal opportunity employer.

EEO Statement:

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.