Analyst Quality Control

• Tests and analyzes raw materials, in-process samples and products such as chemicals and Active Pharmaceutical Ingredients to determine stability, purity, chemical content, and other characteristics.
• Follows standardized formulas or experimental procedures. Documents test results. Communicates status of test results.
• Provides technical expertise to internal customers and other lab personnel.
• Interacts with internal operations and other technical personnel, as well as J&J and contract laboratories as necessary.
• Reviews peer laboratory data to ensure accuracy and completeness.
• Perform and document stability pulls as assigned.
• Show strength on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train laboratory personnel on these techniques.
• Assures accurate and timely input of QC data to information systems: e.g.: ERP, databases, etc.
• Coordinates and performs calibration of new laboratory instruments and equipment to ensure reliable, prompt, precise and accurate test data.
• Troubleshoots and performs minor maintenance/repair of lab instruments. May coordinate and oversee external vendors during the repair of laboratory instruments for minor maintenance.
• Responsible for the setup, IQ, OQ and PQ of new instrumentation and equipment in the QC laboratory as assigned.
• Responsible for leading or collaborating on investigations (OOS, OOT, invalid assays and other laboratory related non-conformances including investigations of audit observations) as business needs require.
• Investigate or support investigation of aberrant data, results, atypical events occurring within the lab, and audit observations by supporting cross functional investigation teams to identify root cause, evaluate technical or product impact including the use of root cause analysis tools (K-T problem analysis, Ishikawa, 5Whys).
• Maintain an adequately supplied, properly cleaned and safe analytical chemistry laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices.
• Review and revise existing SOP’s and other lab documents as necessary.
• When applicable, adapt existing methodologies to support manufacturing and new products
• Train laboratory personnel as it relates to specific operations and procedures by instruction and demonstration.
• Maintain regulatory required documentation, which is current, legible, readily understood, complete and accurate to ensure compliance with procedures and specifications.
• Supports both short and long term projects meeting established deadlines. Responsible for leading and sustaining various projects as assigned.
• Responsible for handling controlled substances in compliance with applicable state and local law and J&J requirements.
• Performs other appropriate duties assigned by QC management.
• Must be willing to work a flexible schedule to support shift operations; be available for overtime work on a scheduled or emergency basis.
• Maintain a clean and orderly workspace.

• Complete understanding and working knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances associated with Johnson & Johnson Innovative Medicine.
• Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures.
• Successfully completes regulatory and job training requirements.
• Makes a positive contribution through demonstration of ability to improve upon current laboratory practices and QS systems and through ability to learn new skills, procedures and processes.
• Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include: wearing appropriate personal protective equipment; recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses); properly labeling and storing chemicals; plus all other relevant job requirements.
• Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
• Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

• Zero to two years’ experience is required
• A bachelor’s degree (B.A./B.S.) from a four-year college or university in a science related field involving wet chemistry and/or basic laboratory functions, or a two-year technical degree in a science or laboratory related field is preferred.

• Ability to make independent decisions within general guidelines and to work under minimum supervision.
• Must have proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment.
• Proficient with Microsoft Office software programs, including MS Outlook.
• Ability to accurately enter data into computer using software applications for data entry and word processing.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to perform under stress in cases of emergency, critical or hazardous situations.
• Ability to work with others in a team environment.
• Proven ability to prioritize work of self and to ensure deadlines are met.
• Strong interpersonal and consultative skills.

• Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure manuals.
• Write technical reports, appropriate business correspondence and standard operating procedures.

• Work with mathematical concepts such as probability and statistical inference.

• Work with mathematical concepts such as probability and statistical inference.
• Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
• Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, co-relational techniques, sampling theory, dimensional analysis, linear regression, ANOVA, and factor analysis.

• Define problems, collect data, establish facts, and draw valid conclusions.
• Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

• Ability to make independent decisions within general guidelines and to work under minimum supervision.
• Must have proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment.
• Working knowledge of analytical instrumentation use and routine preventative maintenance. Ability to trouble-shoot instrumentation malfunctions following ICMS investigation protocols.
• Proficient with Microsoft Office software programs, including MS Outlook.
• Ability to accurately enter data into computer using software applications for data entry and word processing.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to perform under stress in cases of emergency, critical or hazardous situations.
• Ability to work with others in a team environment.
• Proven ability to prioritize work of self and to ensure deadlines are met.
• Strong interpersonal and consultative skills.

• While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel; and talk or hear.
• The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and smell.
• The employee must frequently lift and/or move up to 10 pounds and may occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• Must be able to qualify for respiratory protective equipment use.