Senior Quality Operations Specialist

Senior Quality Operations Specialist needed!

Overview:

The Senior Quality Operations Specialist is responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures, and will support review of deviations, investigations, protocols to support the release of materials and products.

This individual will be responsible for supporting day-to-day Quality Operations activities relating to support manufacturing and the release of products manufactured. The individual will be collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

Shifts (can be considered for both shifts): Sun-Wed, 7am-6pm & Wed-Sat, 7pm-6am

Essential Functions and Responsibilities:

• Perform real-time, on-the-floor support for escalations to ensure compliance with GMP,GDP, 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 escalate to management.
• Support the schedule and coordinate daily activities ensuring conformance to the daily schedule.
• Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
• Review executed documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
• Issuance of lot numbers and supporting documentation as needed for the shift.
• Support release of drug products and materials.
• Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
• Review of Quality System records for compliance.
• Work in a cleanroom with biohazards, human blood components, and chemicals.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Education and Qualifications:

• A minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
• Minimum of 5 years of experience in biopharmaceutical-based GMP aseptic manufacturing
• Proficient knowledge of cGMP regulations.
• Perform routine activities with minimal oversights.
• Prior experience with review of Manufacturing and/or QC data specific to cell therapy testing preferred.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Must be skilled in planning and organizing, decision-making, and building relationships
• Able to effectively work in a dynamic / fast-paced environment
• Extremely detail oriented with strong technical skills.
• Knowledge of MasterControl is preferred.
• High level of accountability and ownership.
• Demonstrate a sense of urgency ability to recognize time sensitivity.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multidiscipline teams.

Physical Requirements:

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

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must be able to work in a cleanroom lab with biohazards / various chemicals.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing up to 45 pounds.
• For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
• Must not be color blind.
• Must have 20/20 near vision in both eyes (can be corrected).

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 position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.