QC Manager

Precigen, Inc•Germantown, MD

6d•$85,000 - $115,000

About The Position

The QC Manager is responsible for overseeing a team of QC Analysts and maintaining the QC Laboratory in a state of cGMP compliance. This role involves training, coaching, and developing QC staff, as well as developing, revising, and reviewing SOPs, qualification/validation protocols, and reports. The manager will also write deviations, CAPA's, and own change controls, while reviewing and providing guidance for deviations/CAPA's generated by QC Analysts. A key responsibility is reviewing invalid assays and leading investigations, as well as participating in OOS investigations. The role ensures all analytical data generated by the QC lab is initiated on time and completed within established turnaround times (TATs). This includes reviewing QC documentation such as equipment logbooks, solution preparation records, cell line records, and TRFs, and ensuring test results are entered into appropriate reports. The QC Manager will track and trend Reference Standards, Assay Controls, and Critical Reagents, as well as equipment cleaning, preventative maintenance (PM), and calibration schedules. Reviewing equipment IQs and re-qualifications, and driving continuous improvements in QC processes and procedures are also essential. Other duties as needed will be performed.

Requirements

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.
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

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