Analyst Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at  https://www.jnj.com/innovative-medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  https://www.jnj.com/. 

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Analyst Quality Control

GENERAL PURPOSE OF JOB

Conducts and analyzes chemical and physical laboratory tests/results for raw materials, intermediates and final products to ensure compliance with company standards and regulatory and customer requirements.  Provides technical laboratory expertise to internal customers and other lab personnel.  Secondary functions involve supporting lab improvement projects, method validations, stability analysis, and equipment qualifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.

ADDITIONAL POSITION REQUIREMENTS

• 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.

QUALIFICATIONS 

EDUCATION and/or EXPERIENCE

• 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.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• 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.

LANGUAGE 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.

MATHEMATICAL SKILLS

• 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.

REASONING ABILITY

• 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.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• 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.

PHYSICAL DEMANDS 

• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via  https://www.jnj.com/contact-us/careers.  Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

Preferred Skills:

AI Judgement Integration, Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy