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Manatí, PR, US

Sr. QC Analyst-9890130124

Description

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

Responsible for performing analytical testing of purified water, gases, raw materials, packaging components, intermediates, bulk, and finished products according to specifications. 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. Prepare the laboratory weekly schedule and assist QC Analysts. Work with non-routine projects, such as method transfers, method validation cleaning, and process validation. Reviews/approves analytical data generated by peers according to approved procedures and regulations. Assist the supervisor in laboratory investigations and data approval in LIMS system. May act as supervisor upon delegation authority, if necessary. 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 applicable system. Documents analytical data in a legible manner at time of execution following Current Good Manufacturing Practices (cGMP's). Updates testing status on Laboratory visual boards and assures compliance with the product cycle time. Experience managing compliance documentation, laboratory quality deviations and CAPAs. Operates and maintains Laboratory instrumentation following established methods and procedures. Assures all equipment is properly calibrated and Preventive Maintenance (PM) prior to use. 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. Trains and gives technical support to less experienced Quality Control Analysts. Works with laboratory personnel in coordinating samples arrival and working schedules. Verifies and reviews data of cleaning and process validation samples and all laboratory data for raw material, in process and finished goods in accordance with the established procedures. Works with non-routine projects, such as method transfers, method validation cleaning, and process validation. Identifies continuous improvement opportunities, applying PE tools. Coordinate equipment calibration, preventive maintenance activities or repair, as required. 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. Notifies any violation or deviation to his/her immediate supervisor or Compliance Area Official. Provides support to the ISO 14001 Team member of his department and to the Environmental Management System Coordinator for training and continuous improvement of the organization's ISO 14001 System. Follows all guidelines established in the organization for the continuous improvement of the ISO 14001 System. Follows the proper indicators as established in the SOPs for the chemical substances and hazardous waste handling or disposable, as applicable. 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 five (5) years of working experience in the Pharmaceutical industry is required. PR chemistry Licensed is required. PE certification is preferred. This position requires good knowledge of cGMPs and laboratory testing techniques. 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. 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. 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. Physical requirements of the position include carrying less than 10 pounds occasionally, and requires occasionally pull and push, bend forward and backwards, twist waist and neck, hand and arm; frequently stand, walk, sit, talk, listen, grab with one or both hands; and constantly close vision, handwriting, use of computer and general office machines / tools, laboratory equipment and instruments.

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)
Travel:Yes, 10% of the time
Job Function: Quality Control