Lead QC Associate II
NCBiotech, Raleigh, NC, United States
Lead QC Associate II
Position Overview
The Lead QC Associate II role in Quality Control Microbiology is crucial for overseeing and guiding the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as for effectively training junior analysts in these areas. The incumbent will operate largely autonomously, ensuring technical issues are promptly escalated to laboratory management. Overtime and temporary shift changes will be required to support programs that have samples with short testing windows (e.g., bioburden 12-hours).
Job Description Major Accountabilities
Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include, but is not limited to, Bioburden, Endotoxin, Culture Purity, and Microbial Identifications.
Reviews technical data, authors routine and periodic laboratory reports (e.g., EM trend reports) and contributes to technical documentation and assessments.
Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance.
Assists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily, weekly, and non-routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participate or lead laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties, as assigned.
Knowledge, Skills or Abilities
Strong working knowledge of aseptic techniques and behaviors
Effective communication, both written and verbal
Superior technical writing and problem-solving skills
Ability to aseptically gown into classified manufacturing spaces
Ability to complete work both independently with minimal supervision
Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
Ability to effectively collaborate with coworkers and internal clients
In-depth understanding and working knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to learn and incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Expertise with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systems
Must be flexible to support 24/7 manufacturing facility
Minimum Education Requirements
High School Diploma and at least 8 years of laboratory experience in a cGMP environment; or
Associate’s degree in Life Science, Pharmaceutical, or related field with at least 6 years of laboratory experience in a cGMP environment; or
Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment
Preferred Experience
BioWork Certificate
Physical Requirements
Will work in environment which may necessitate repiratory protection
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time (240 minutes)
Ability to sit for prolonged periods of time (240 minutes)
Ablity to conduct activities using repetitive motions that include wrists, hands, and/or fingers
Ability to conduct work that includes moving objects up to 33lbs
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
Will work in warm/cold environments (0-100F range)
* #LI-Onsite
EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
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Job Description Major Accountabilities
Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include, but is not limited to, Bioburden, Endotoxin, Culture Purity, and Microbial Identifications.
Reviews technical data, authors routine and periodic laboratory reports (e.g., EM trend reports) and contributes to technical documentation and assessments.
Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance.
Assists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily, weekly, and non-routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participate or lead laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties, as assigned.
Knowledge, Skills or Abilities
Strong working knowledge of aseptic techniques and behaviors
Effective communication, both written and verbal
Superior technical writing and problem-solving skills
Ability to aseptically gown into classified manufacturing spaces
Ability to complete work both independently with minimal supervision
Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
Ability to effectively collaborate with coworkers and internal clients
In-depth understanding and working knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to learn and incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Expertise with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systems
Must be flexible to support 24/7 manufacturing facility
Minimum Education Requirements
High School Diploma and at least 8 years of laboratory experience in a cGMP environment; or
Associate’s degree in Life Science, Pharmaceutical, or related field with at least 6 years of laboratory experience in a cGMP environment; or
Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment
Preferred Experience
BioWork Certificate
Physical Requirements
Will work in environment which may necessitate repiratory protection
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time (240 minutes)
Ability to sit for prolonged periods of time (240 minutes)
Ablity to conduct activities using repetitive motions that include wrists, hands, and/or fingers
Ability to conduct work that includes moving objects up to 33lbs
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
Will work in warm/cold environments (0-100F range)
* #LI-Onsite
EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
#J-18808-Ljbffr