Associate Analyst Quality Control

Job description

Job Description

Requisition ID: 9060190308


Janssen Pharmaceuticals, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices. Janssen Pharmaceuticals Inc. is currently recruiting for an Associate Analyst Quality Control located in Athens, GA.

RESPONSIBILITIES:
- Sets up, operates and cleans production equipment used to produce intermediate or finished products for Active Pharmaceutical Ingredients, medical device raw material components, or other products as directed; Completes all associated support activities in the production of these products

- Assures that QC Labs run in a safe, clean and environmentally sound manner.

- Show strength on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train laboratory personnel on these techniques

- Maintain sample control of all samples submitted to the laboratory.

- Perform and document stability pulls as assigned.

- Troubleshoots and performs minor maintenance, calibration and repair of laboratory instrumentation.

- Prepare or handle chemicals associated with the process, including Buffer Solution pH, 90% Alcohol, Hydrochloric Acid, Sodium Hydroxide, Sodium Phosphate, Sodium Chloride, Nitrogen, and assorted polymers. Monitor inventories of chemicals and supplies to ensure continuity of raw material supply for testing.

- Input of QC data to information systems: e.g.: ERP, databases, planning database, etc.

- Identify and implement process improvements within the change control system and related to safety, environmental, quality, compliance, productivity, yield, and cost, partnering with all Cells and COE's as applicable.

- Review SOP's and other lab documents as necessary.

- Responsible for authoring investigations (OOS, OOT, invalid assays and other laboratory related non-conformances including investigations of audit observations) as business needs require

- Support the implementation of meaningful CAPA and monitor effectiveness of CAPA

- Responsible for Documentation Updates (procedures, work instructions, technical documents) in an electronic management system

- Peer review of analytical data and test results

- Responsible for sustaining various projects as assigned.

- Provide training to other analysts.

- Be available for overtime work on a scheduled or emergency basis and shift work.

- Perform all other duties assigned as required.

- Successfully completes regulatory and job training requirements

- Remains current in profession and industry trends.

- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA and DEA; Adheres to with all company and site policies and procedures.

- Administrative duties including on-site archiving, metric reporting, and other duties as assigned

- Investigates 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)

- Provide documentation support for SOP/ Test Method revisions, identify and communicate necessary document changes to management group to ensure timely revision to all SOP and test methods records and review and approve SOP and test method record revisions for the Cell or COE.

- Makes a positive contribution through demonstration of ability to seek out assistance from co-workers as needed, to suggest ways to improve upon current operations practices and systems; and to learn new skills, procedures and processes.

- Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.

- Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

- Understand 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), maintaining proper housekeeping at all times, plus all other relevant job requirements.

Desired profile

Qualifications
- Associates degree (A.A.) or two (2) years of college or technical school training required

- Prefer 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.

- Must be able to read, write, and understand Basic English and read and interpret documents such as safety rules, operating and maintenance instructions, government regulations and procedure manuals.

- Write reports and business correspondence.

- Skills to work with mathematic concepts for example probability and statistical inferences.

- Apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

- Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlational techniques, sampling theory, and factor analysis.

- Ability to define problems, collect data, establish facts and make scientific based conclusions.

- Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

- Minimum of 2 years in a Quality Control (GMP regulated) Laboratory is required

- Energy, enthusiasm, dedication, and courage.

- Lab Operations and Quality processes/systems in a GMP Lab setting.

- Lab Systems (e.g., LIMs, Documentum, Non-conformance handling, Change Control) is required

- Familiar with a variety of laboratory equipment, such as: GC.HPLC, karl fisher, etc.

- Project Management Skills are preferred

- Position will be in Athens GA and may require up to 10% travel.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Georgia-Athens-
Organization
Noramco, Inc. (6109)
Job Function
Quality Control
Requisition ID
9060190308