Senior Quality Release Specialist - Nights-Wednesday to Saturday - 9pm-8am
Senior Quality Release Specialist - Nights-Wednesday to Saturday - 9pm-8am
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
The Senior Quality Release Specialist will support review of documentation and support releasing of materials and products. Th Sr Quality Release Specialist will also ensure compliance to Iovance procedures by supporting lot closure and deviation reviews.
Shift: Wednesday to Saturday from 9pm8am
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 batch records and related production documentation ensuring resolution of all identified issues prior product disposition.
- Collaborate with internal functions to address all identified issues in a timely manner. Determine if the issue needs to be documented in the Quality System.
- Coordinating release tasks as assigned to the Quality Release team by the schedule.
- Collaborating lot release dates with cross functional teams for clinical release
- Reports errors deficiencies discrepancies and observations to management that could impact product Quality on release.
- Perform disposition of incoming materials and finished product.
- Initiate and review of documentation for release.
- Issuance of labels.
- Support generation of Quality Metrics.
- Ensure timely lot closure.
- Support and review deviations CAPAs Laboratory Investigations temperature excursions and other nonconformances.
- Perform miscellaneous duties as assigned.
Required Education Skills and Knowledge
- a minimum of 8 years of related experience with a Bachelors degree; or 6 years and a Masters degree; or a PhD with 3 years experience; or equivalent experience.
- 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 QC data specific to cell therapy testing.
- Strong administrative skills including use of Microsoft Word Excel and PowerPoint.
- 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.
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 andexert 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 problemsolving analysis and discretion; ability to handle workrelated 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.
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 .
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
Full-Time
