Analyst Quality Control

Johnson & Johnson Innovative Medicine•Malvern, PA

1d•Onsite

About The Position

The QC Analyst conducts biochemical, microbiological, and/or general chemical testing of raw material, in-process, or final product samples submitted to the QC laboratories. The position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations.

Requirements

BA/BS Equivalent
0-2 years of related experience
Level appropriate knowledge of analytical technologies used in the QC laboratory
Skilled in performing basic testing within the QC laboratory
Experience, knowledge and understanding using Good Laboratory Practices (GLP) and basic knowledge of current Good Manufacturing Practices (cGMP) related to the QC laboratory
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Makes GMP laboratory decisions both independently and with guidance from QC supervision
Performs independent troubleshooting and has basic root cause analysis skills.
Works directly with supervision for resolution of complex issues
May occasionally assist the supervisor in establishing priorities within the functional
Works with supervision on routine tasks.
Does not perform non-routine tasks.
Begins to demonstrate technical skills to perform job functions.
Learning departmental operations.
Works with the assistance/support of senior levels in QC functions.
Suggests basic improvements on work assignments.
Escalates issues to management in a timely manner.

Nice To Haves

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

Responsibilities

Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
Conducts analytical methodologies and testing within the QC laboratory
Performs peer review of laboratory data
Utilize electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing
Maintains knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
Follows compendial (USP, EP, JP, etc.) requirements and standards for QC testing
Conducts general housekeeping activities and supply ordering/receipt
Supports 24 hr manufacturing schedule
Maintains inspection readiness system and activities for the site.
Proactively evaluates and facilitates remediation of compliance risks.
Participates in quality audits, Inspection activities, and responses.
Remains current in skills and industry trends.
Facilitates or participates in any and all required meetings related to quality control.
Carries out duties in compliance with all local, state, federal, and global regulations and guidelines.
Complies with all company and site policies standards and procedures.
Successfully completes regulatory and job training requirements.
Perform Technical writing (SOP, TMD, Protocol/Validation Reports).
Supports calibration and/or preventative maintenance.
Execute process excellence tools and methodologies.
Perform project management functions.
Apply statistical concepts to laboratory data.
Support of New Product Initiative (NPI).
Support QC invalid assay records and non-conformance investigations.
Support change management processes including formal change controls by evaluating the proposed changes, documenting impact assessments, and providing feedback on implementation plans.
Train new QC personnel.