GMP, QUALITY CONTROL ASSOCIATE II (Durham, NC, US, 27710)
School of Medicine:
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Job Title: GMP, Quality Control Associate II
The GMP, Quality Control Associate II will support the development, qualification and execution of analytical methods to enable release of cellular products. With minimal oversight and/or independently, this position will be executing specialized testing of cellular products for clinical trials and commercial operations, supporting GMP production of cellular products and therapeutics. In addition, this individual will be responsible for environmental monitoring of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical and commercial material for novel cellular therapies. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource.
With minimal oversight by management and/or independently:
- Perform pharmaceutical development and successful GMP release including: Analytical development, assisting the QC Manager and Product Development team in development of specific release and characterization methods
- Aid in qualifying methods for product release and complete comprehensive characterization of clinical lots.
- Complete GMP testing in line with ICH and regulatory guidance.
- Lead qualification testing of cellular therapy products including, tech transfer and associated testing under GMP conditions.
- Execute and document development and GMP activities in compliance with regulatory requirements.
- Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
- Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
- Write and review development reports; write protocols for use in GMP facility and SOPs for GMP production, and present data to project teams and larger settings.
- Write, coordinate, and review QC deviations, non-conformances, CAPAs, out of specifications, complaints, and all associated required reporting.
- Ship and prepare samples for outside vendors for quality control testing. Engage external vendors for coordination of quality control testing.
- Operate and maintain equipment utilized in characterization and qualification testing.
- Perform routine environmental monitoring of the GMP Facility to ensure facility remains in state of microbial control.
- Execute activities and serve as key resource for junior staff in a cleanroom environment while following associated GMP and regulatory guidelines.
- Independently support project teams for Quality Control input and contributions on event/deviation composition, including associated investigations, assessment for impact/risk, root cause analysis, and CAPA requirements/documentation
- Represent the Quality Control Department at project meetings and provide guidance.
- Track and trend Quality Control metrics and identify areas of concern.
- Participate in multiple programs in varying phases of development or that require varying levels of Quality Control involvement.
- In conjunction with the QC Associate Director, develop, write, and review analytical, equipment and process validations.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
- Required: Bachelor's degree
- 5 years of experience in a GXMP or similar regulated environment.
- Experience in training Quality personnel
- Prior laboratory experience in product testing.
- Experience in preparing for external audits and/or site visits.
- Experience in reviewing raw materials, test and analytical method results, supplies, and manufactured products for acceptability.
A Master's or PhD can substitute for experience
- Proficient knowledge in GLP, GMP, and/or GTP
- Demonstrate leadership, organizational, and time management skills and the ability to handle a multitude of tasks.
- Have ability to train other staff members effectively.
- Attention to detail in document review.
- Team player with sense of urgency to carry out tasks in a timely and accurate manner.
- Ability to interact well with employees at all levels.
- Strong organizational skills.
- Excellent verbal, written, and interpersonal skills.
- Possess good problem-solving skills.
- Adapt to changing priorities effectively.
- Able to work effectively independently or in a team environment.
- Has served as final signature for QC release of test and analytical method results, raw materials and finished products.
- Has served as QC department representative at various functions and report back to the QC department
- Experience in leading laboratory investigations and/or CAPA(s)
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
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