QA Specialist I, Raw Material Release

CONTRACT-TO-HIRE

MUST HAVES:

• Bachelor’s degree in Science, Engineering, or a related technical discipline or equivalent industry experience with 1 -2 years’ experience in a GMP Manufacturing setting or similar regulated environment
• Prior experience and ability to work in an aseptic processing environment and familiar with aseptic gowning.

SHIFTS AVAILABLE:

• Sunday to Wednesday, 2:30pm-1:30am
• Wednesday to Saturday, 2:30pm-1:30am

Position Overview:

The Quality Assurance Specialist I, Raw Material Release will support review of documentation and support releasing of materials and products.

Essential Functions and Responsibilities

• Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review of documentation associated with Raw materials, components in support of manufacturing operations
• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition, as required.
• Review of deviations as assigned.
• Revision of documents as assigned.
• Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
• Disposition incoming materials.
• Preparing supporting documentation for release of materials.
• Issuance of labels, as required.
• Support lot closure
• Other projects as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s Degree in Science, Engineering, or a related technical discipline with at least 2 years of experience in a regulated industry or an advanced degree without experience.
• Prior experience in cell and gene therapy preferred.
• Working knowledge of cGMP regulations.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Attention to detail.
• Knowledge of QMS systems is a plus.

Preferred Education, Skills, and Knowledge

• Knowledge of QMS systems is a plus.
• The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

• This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.