Mon-Friday 8a-5p-There may be some weekend coverage needed. Manager to detail during candidate meetings.
External Vendor/partnership experience and they will need out of specification investigation experience and change control experience. Would also prefer someone from the cell and gene therapy industry.
Overview
The Senior Quality Control Specialist - External Operations is responsible for the review of the executed test methods and raw data for lot release. This role must have a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to: Lot release; Method qualification and validation, Technology Transfers, and writing/review of QC procedures. Experience working in a GMP-regulated environment is essential, including knowledge of health authority expectations for novel and complex oncology programs.
Essential Functions and Responsibilities
Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
Performs review and approval of CMO/CTL change controls.
Performs data analysis of CMO release testing to support product lot release with adherence to turnaround times.
Issue and write change controls and CAPAs when required.
Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents.
Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
All duties are performed with minimal supervision and oversight.
Performs other duties as assigned.
Required Education, Skills, and Knowledge
Bachelor's degree in a relevant discipline (biological sciences or equivalent)
Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
Must have experience with OOS investigations, deviations, change controls and CAPAs.
Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)
Extremely detail-oriented with strong analytical, written, and verbal communication skills
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Demonstrate sense of urgency; ability to recognize time sensitivity.
Flexible and adaptable style with an eagerness to take on challenges.
Problem solver who not only identifies issues but leads efforts to resolve them.
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Successfully interface with multi-disciplined teams
High level of ownership and accountability.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
Preferred Education, Skills, and Knowledge
Bachelor's degree with 5 years of relevant experience with cell therapy products 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 wear appropriate Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
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
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 when not in a lab setting.
Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
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 deadlines
Work Environment:
This job operates in a professional or remote office environment and 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.
***Pay rate is commensurate with experience. Target pay rate is $35-60/hr***