QC Manager at Precigen, Inc

Germantown, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Aug, 26

Salary

115000.0

Posted On

15 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Team Management, cGMP Compliance, SOP Development, CAPA, Change Control, OOS Investigations, Analytical Testing, qPCR, HPLC, ELISA, Cell-based Assays, Quality Control, Audit Support, Documentation, Validation Protocols, Problem Solving

Industry

Biotechnology Research

Description

Job Title: QC Manager 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 * Track equipment cleaning/PM/Calibration schedules * Review equipment IOQ’s and Re-Qualifications * QC Process/Procedure continuous improvements * 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.

Responsibilities

Oversee a team of QC Analysts and maintain the QC Laboratory in a state of cGMP compliance. Responsibilities include reviewing analytical data, managing deviations and CAPAs, and ensuring timely completion of assays.