HireDiversity

Manatí, PR, US

QC Analyst 2 (4 positions)-9915130124

Description

Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting four (4) Quality Control Analyst, located in Manati, Puerto Rico.

Janssen Ortho LLC., provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologic (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

Responsible for performing analytical testing of purified water, gases, raw materials, packaging components, intermediates, bulk, and finished products with a minimum of error. Responsible to document and review data according to approved procedures and cGMPs, escalate any Out-of-Specification results (OOS) to management, and document quality investigations and CAPAs Performs analytical testing as per approved test method and laboratory procedures on a timely manner and reports to management any suspect results immediately. Acquires data using Millennium system is applicable. Documents analytical data in a legible manner at time of execution following cGMPs. Updates testing status on Laboratory visual boards and assures compliance with the product cycle time. Reviews analytical data generated by peers according to approved procedures and regulations. Escalates and documents any laboratory trend and/or deviation per established procedures. Follows Good Laboratory Practices (GLP) and Standard Operating Procedures. Assures all equipment is properly calibrated and Preventive Maintenance (PM) prior to use. Prepares, labels and keeps solutions properly stored according to current established procedures. Keeps all solutions, samples, standards, batches, and materials used during the analysis until data is approved. Maintains the satellite and accumulation areas at the Laboratory in full compliance with regulations and optimum housekeeping conditions. Observes all company policies, procedures, programs, systems, rules, and applicable regulations at all times of all compliance areas including but not limited to Safety, Environmental, Quality, Records Managements, Human Resources, Security, and others, and encourages co-workers to do so. Follows the proper indicators as established in the SOPs for the chemical substances and hazardous waste handling or disposable, as applicable. Participates in projects, programs and special activities that the company promotes geared toward establishing its strategic goals. Other duties as assigned by immediate supervisor.

Qualifications


A minimum of a Bachelor Degree in Chemistry is required. A Master's Degree is preferred. A minimum of three (3) years of working experience in the Pharmaceutical industry is required. Knowledge of cGMPs and laboratory testing techniques is required. Must be able to work in a frequently exposed environment of : explosives , toxics, chemicals, biological agents, acids with chemical bases, oils, solvents, gases; and occasionally exposed to machines in movements and noise. Interpret and manage an extensive variety of data and technical instructions in mathematic or diagrammatic form. Knowledge reading and interpreting documents such as: safety rules, operating instructions, maintenance and procedure manuals, and regulations. Ability to sum, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals, knowledge interpreting graphs; calculate proportions, percents and volumes, are required. Candidates must be able to calculate conversions and dilutions. Apply mathematical operations to frequency distribution, reliability and validity of tests, analysis of variances, correlation techniques, sampling theory, and factor analysis. Apply formulas to chemical analysis. Perform repetitive tasks. Work in teams and independently. Good planning and coordination skills. Must be able to meet deadlines and work under pressure and precision. Proven oral and written communication skills in English and Spanish are required. Computer proficiency in MS Office (Word, Excel and Power Point) is required. Availability to work a regular or staggered shift as well as flexibility to work extended hours, irregular schedules, holidays and weekends based on the operational needs is required. Availability to travel ten (10%) of the time within Puerto Rico is required. The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions of this job. Reasonable accommodations must be made to enable individuals with disabilities to perform the essential job functions. The position physical demands are classified as light; employee carries less than 20 pounds; occasionally is required to walk, sit, carry, push and pull, operates hand controls, climb stairs and steps, twist hands, perceive depth, grab with hands, assemble, write, used keyboard, use mechanic and electronic tools, and wash; and frequently is required to stand, perceive odors and colors, close vision, and fine manipulation.

BE VITAL in your Career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Puerto Rico-Manatí
Organization: Janssen Ortho LLC (2162)
Relocation: Eligible
No
Travel:Yes, 10% of the time
Job Function: Quality Control