The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews.
Monday to Friday-Standard Hours. 4 roles needed.
Position is 100% on site.
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 escalate to management.
Responsible for providing quality oversight for site manufacturing operations and quality control at the iCTC.
Accurate and timely maintenance and review of procedures, methods, protocols, and reports as required
Collaborate with internal functions to address all identified issues in a timely manner. Determine how best to document issues requiring investigation within the Quality System.
Providing Quality and compliance oversight to manufacturing, QC, and MSAT
Coordinating deviation and investigation reviews to support release of final product and materials.
Ensure accurate and timely review of manufacturing and laboratory investigations
Identifying and escalating any trends to management
Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
Ensure deviations and investigations do not adversely impact timely lot closure, as required.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
A Bachelor's Degree in Science, Engineering, or a related technical discipline.
At least five years of experience in a regulated industry.
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 multidisciplined teams.
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 deadline
Work Environment:
This position will work in both an office and a manufacturing lab setting.
When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.