QC Reviewer

Summary:

QC Reviewer reports to the Manager, QC Support Services and performs a range of work activities including:

Essential Position Responsibilities*:

• Principal responsibility is to perform a technical and compliance review of quality control data generated in the QC labs prior to subsequent management review.
• Following Standard Operating Procedures (SOPs) in performing CGMP data review generated by QC laboratories.
• Assist with the development/writing/review of Test Methods, SOPs, Work Instructions and all other documentation required in accordance with established and current quality requirements.
• Participating in the review of maintenance, qualification and calibration records and documents of laboratory equipment in QC.
• Participating in Laboratory administration, including Out of Specification and non-conformances arising, progression of change controls, laboratory investigations/audits, SOP reviews and closure of assigned activities in QC.
• Review of environmental monitoring sampling and testing performed by QC Microbiology.
• Participating in review and approvals of method qualification and validation of QC procedures as needed.
• Coordinate with Quality Control laboratory managers and ensure timely release of material/ stability data to meet the organization’s goals.
• Performance of test method activities as needed.
• Performance or Assistance with IOQ/IOPQ validation activities as nee

Minimum Education and Experience Requirements for Competency:

• Must have at least an AS/AA in science-related field.
• Preferred Bachelor’s degree in Biochemistry, Biology or Microbiology or related field
• At least 2 years of experience in a GMP role; experience in a GMP laboratory or review-based role highly preferred. Other regulated experience may offset experience requirements.
• Prior experience with biological testing or review for TCID-50, CE-SDS, PCR, Cell-based bioassays and ELISA highly preferred.
• Prior experiences with data tracking software systems such as LIMS, EMPOWER and/or MODA is preferred.
• Must be familiar with GMP/GLP practices and ICH and FDA Guidelines.
• Strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
• Ability to work independently with minimal supervision.

Physical Requirements: (rows or statements that are not required to perform the duties of the position)

This job requires the employee to perform the following physical activities:

• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Reaching
• Grasping
• Walking
• Pushing
• Hearing
• Talking

This job requires exposure to the following:

• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

This job requires the following visual acuity requirements:

• preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).