Quality Control Analyst II

askbio; Durham (NC); On-site; USD 68,000 - 88,000; Full time

Job summary

AskBio in Durham, NC is seeking a Quality Control Analyst II to perform routine analytical testing in our GMP QC laboratories. You will contribute to quality events and support the testing of assays and methods.

The role requires a bachelor’s in a scientific field and 2+ years in a cGMP QC lab. You will work cross-functionally with QC, QA, Production and AD teams, ensuring GMP documentation and ongoing process improvements.

Qualifications

• Bachelor’s degree in a scientific field.
• 2+ years in a cGMP Quality Control lab in pharma/biotech.
• Ability to manage multiple projects and work independently.
• Excellent verbal and written communication.
• Strong teamwork and organizational skills.

Responsibilities

• Perform routine analytical testing (cell-based potency assays, ddPCR, qPCR, ELISAs, HPLC).
• Prepare solutions, maintain cell lines, manage inventory and day-to-day lab tasks.
• Track and trend analytical data; maintain GMP-compliant records.
• Support qualification of equipment and methods; train new analysts.
• Collaborate with QC/QA, Production, and other departments; drive SOPs.

Skills

cGMP

Analytical testing

qPCR

ddPCR

ELISA

HPLC

LIMS

Training

Education

Bachelor’s degree in a scientific field

Tools

LIMS

Job description

Quality Control Analyst II will be responsible for performing routine testing on analytical methods in the GMP Quality Control laboratories and supporting quality events. This position is based on site in Durham, NC and reports to the Associate Director, Quality Control.

Job Responsibilities

• Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques.
• Prepare laboratory solutions, maintain cell lines, maintain inventory of materials and other day-to-day laboratory activities.
• Participate in tracking and trending activities for analytical data.
• Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner.
• Support activities for qualification of laboratory equipment and analytical methods.
• Serve as a trainer for applicable methods for new analysts.
• Support Quality Control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, etc.
• Work closely with Analytical Development, Quality Control, Quality Assurance, Production and any other relevant departments.
• Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
• Participate in continuous improvement projects in the AD and QC labs.
• Revise processes, work instructions, SOPs, forms, protocols, and reports.
• Own deviations, CAPAs, change controls, and OOS investigations driving them to closure in accordance with internal timelines and external partners.

Minimum Requirements

• Bachelor’s degree in a scientific field.
• 2+ years’ experience in a cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field.
• Ability to handle multiple projects/teams simultaneously.
• Ability to work independently in a fast-paced, highly interactive environment with minimal supervision.
• Excellent verbal and written communication skills.
• Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
• Excellent self-organization skills with ability to envisage, design, and implement organizational systems to improve efficiency and function of working teams.

Preferred Education, Experience and Skills

• Experience with cell-based assays, PCR testing, and/or HPLC testing.
• Experience working within a cGMP Quality Control LIMS system.
• Experience working with deviations, CAPAs, change controls, and/or OOS quality events.

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at [phone] or sending us an email at [e-mail].