Avantor, Inc. Batch Release Lead in Phillipsburg, New Jersey
Job SummaryWorks 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.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)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.Plans, develops, and implements quality assurance programs.Prepares routine and special reports to staff, and regulatory agencies as required.Implement correction action in processes as required. 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 of 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 VWR.Develops and executes 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 required in the assigned audits.Ascertain 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.Formulates and maintains Process Validation, QC objectives based on company vision and objectives.Interacts with associates, clients and suppliers. Must be affable and warm maintaining and guarding for an atmosphere of cooperation, teamwork and respect even in moments of stress.Complete audit paperwork as defined and required.Performs other duties as assigned.QUALIFICATIONS (Education/Training, Experience and Certifications)Bachelor’s degree in science, chemistry or engineering strongly preferredThree to Five years’ experience the pharmaceutical or manufacturing industryBilingual (Spanish and English), a mustKNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)Knowledge in GMP, GLP, GDP and ISO regulationsExperience creating, maintaining and auditing quality programCertified in Quality Program, preferableMicrosoft office (Excel) skills, intermediate levelENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)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 warehouseenvironment. 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.Associate may be exposed to areas with Penicillin, Aspirin, Alcohol, Acetone and other fumes. Personal protective equipment required (safety shoes, respirators, gloves, safety glasses and laboratory coats required.Traveling 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.
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.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.
EEO is the Law (https://media.vwr.com/emdocs/docs/EEO-is-the-law.pdf)
OFCCP EEO Supplement (https://media.vwr.com/emdocs/docs/OFCCP-EEO-Supplement.pdf)
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
3rd party non-solicitation policy
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. For information visit, www.avantorsciences.com and find us on LinkedIn (https://www.linkedin.com/company/avantorinc/) , Twitter (https://twitter.com/Avantor_News) and Facebook (https://www.facebook.com/Avantorinc/) .