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Quality Operations Specialist II
2 months ago
Overview
The Quality Operations Specialist II is a part of the Quality Operations team. The Quality Operations team is responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures. The Quality Operations Specialist II works alongside manufacturing personnel, helping to ensure that the highest standard of work is performed.
Shift:
- Sunday - Wednesday (9am - 8pm)
Essential Functions and Responsibilities
- Helps to ensure compliance to cGMPs and facility 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 batch records and related production documentation, ensuring resolution of all identified issues prior product Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
- Disposition incoming raw materials
- 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
- Maintain and report on Quality Metrics
- Initiate and participate in standard operating procedure (SOP) revisions to improve Maintain and report on Quality Metrics.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations
- Perform miscellaneous duties as assigned
Required Education, Skills, and Knowledge
- A Bachelor’s Degree in Science, Engineering, or equivalent experience.
- At least two years of experience in a regulated industry
- Working knowledge of cGMP regulations
- Prior experience and ability to work in an aseptic processing environment
- Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint
- Attention to details
- Weekend and Shift work required
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.
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)
Physical Demands and Activities Required:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions
- Must be able to lift and carry objects weighing 45 pounds
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.
- Able to work in cleanroom with biohazards, human blood components, and chemicals
- Potential exposure to noise and equipment hazards and strong odors
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.
Iovance is 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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