Manager, Quality Control

Precigen; Germantown (MD); Hybrid; USD 105,000 - 140,000; Full time

Job summary

Precigen in Germantown, MD is seeking a Manager, Quality Control to lead a QC team and maintain a cGMP-compliant laboratory. You will oversee training, SOPs, CAPAs, data review, and regulatory-ready documentation.

The role requires 7+ years in QC within pharma/biotech and at least 2 years in supervision, with hands-on experience in qPCR, HPLC, ELISA, and cell-based assays. Strong leadership and cross-functional collaboration are essential.

Qualifications

• BS degree in Biological Sciences, Bioengineering, or Chemistry.
• 7+ years of QC experience in pharma/biotech under GMP.
• 2+ years of supervisory experience.
• Advanced QC testing experience in pharma/biotech labs.
• Familiarity with analytical tests: qPCR, HPLC, ELISA, cell-based assays.

Responsibilities

• Train, coach, and develop QC staff.
• Develop, revise SOPs, qualification/validation protocols and reports.
• Write deviations, CAPAs and own change controls.
• Review deviations/CAPAs from QC Analysts and provide guidance.
• Lead investigations for OOS events and invalid assays.
• Ensure timely entry of analytical data into reports.
• Review IOQs and re-qualifications of equipment.
• Perform other duties as needed.

Skills

Team management

QC oversight

Documentation

Analytical skills

Regulatory audits

Communication

Training coaching

Education

BS in Biological Sciences, Bioengineering or Chemistry

Tools

qPCR

HPLC

ELISA

Job description

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Manager, Quality Control

Full-time Regular Management - MNG Germantown, MD, US

7 days ago Requisition ID: 1423

Salary Range: $105,000.00 To $140,000.00 Annually

Job Title:Manager, Quality Control

Department: Quality Control - Analytical

GENERAL DESCRIPTION:

• QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.DUTIES AND RESPONSIBILITIES:
• Training, coaching, and development of QC staff
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Write deviations, CAPA’s and own change controls.
• Review/Provide guidance for deviations/CAPA’s generated by QC Analysts
• Responsible for reviewing invalid assays and lead invalid assay investigations
• Participating in OOS investigations
• Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT’s.
• Perform review of QC documentation (equipment logbooks, sol’n prep record, cell line records, TRF’s, etc)
• Ensure test results are entered into the appropriate reports
• Track/Trend Ref. Std, Assay Control and Critical Reagents
• Review equipment IOQ’s and Re-Qualifications
• Perform other duties as needed

EDUCATION AND EXPERIENCE:

• BS degree in the Biological Sciences, Bioengineering, or Chemistry.
• 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays.
• 2+ years of supervisory experience.
• Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories
• Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.

DESIRED KEY COMPETENCIES:

• Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data
• Ability to provide support for regulatory and client audits, as well as interact with clients.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Ability to be self-motivated, proactive, accountable, and flexible
• Demonstrate the ability to develop, coach and mentor key employees.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• High attention to detail, highly organized, and excellent documentation skills
• Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.