Quality Control Analyst II Microbiology Sun-Wed Night 7pm 6am Contract to Hire
Quality Control Analyst II Microbiology Sun-Wed Night 7pm 6am Contract to Hire
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Quality Control Analyst II Microbiology will support quality control testing operations at Iovances Cell Therapy Center (iCTC and/or iPBMC manufacturing site (IOVAA). The quality control testing programs include inprocess and final drug product microbial testing such as bioburden endotoxins mycoplasma gram stain environmental monitoring and sterility techniques. This position works across different shifts. Depending on your assigned shift you may be required to work overtime weekends and holidays to complete assigned work.
Essential Functions and Responsibilities
- Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures standards and GMP regulations.
- Perform environmental monitoring of the cleanroom areas as scheduled.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Support technical problemsolving for issues pertaining to GMP Quality Control
- Support product stability programs including of stability testing stability data analysis and trending and final reporting of stability data.
- Support generation and revisions of documentation such as SOP protocols and reports deviations laboratory investigations CAPAs and change controls
- Act as subject matter expert (SME) on one or more assays and train new laboratory personnel.
- Perform peer review of laboratory data and logbooks.
- Provide input to functional laboratory and cross functional team meetings.SD1
- Operate at a consistent and exemplary level of efficiency producing highquality and accurate results.
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics.
- 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
- Bachelors degree in a relevant discipline (biological sciences or equivalent)
- 38 years of experience in the pharmaceutical industry within a Quality Control role
- Successfully interface with multidisciplined teams
- Extremely detailoriented with strong technical skill
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
- High level of ownership and accountability
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Previous experience with GDP GLP GMP.
Preferred Education Skills and Knowledge
- Advanced degree (MSc. preferred.
- Experience with cell therapy products is a plus.
Physical Demands and Activities Required:
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.
- 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 halfface respirator.
- Able to stand and/or walk 90 (and sit 10 of a work day which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range
- 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 problemsolving analysis and discretion; ability to handle workrelated 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 you may be exposed to various chemical/biochemical exposures including latex and bleach. Additionally there is potential for variable noise levels equipment hazards strong odors and other detergents/sanitizers. 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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 e.
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 ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Contract
