Reference # : 20-00722 Title : Quality Assurance Specialist III/IV, Analytical Location : Gaithersburg, MD Position Type : Direct Placement Experience Level : Start Date : 09/01/2020 Description This position reports directly to the QA Operations Manager.
R esponsibilitiesinclude but are notlimitedto:
Review of analytical records and data generated during the manufacturing and/or testing of vaccines for compliance to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and Standard Operating Procedures (SOPs) and protocols. Records and data include, but are not limited to: Lot release records
Clinical Immunology records
Conducts final review and approval of development, QC and manufacturing-related documentation prior to batch release approval
Preparation of lot release and lot rejection certificates of analysis for review and approval.
Serves as a technical resource or subject matter expert on methods and techniques within Quality Assurance
Review of analytical method qualification and validation protocols and report packages
Review and approval of method and manufacturing technology transfer protocols and reports internally and oversight activities to CDMOs
Provide Quality support and oversight for resolution of deviations and non-conformances related to Quality Control and manufacturing activities, including investigation of Out of Specification results
Provide Quality review and approval for QC/analytical SOPs, test methods, protocols and reports
Provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned
Other duties as assigned
Mi n im u m Requirements:
BS with 5+ years GxP industry experience
Excellent understanding of Quality Assurance systems
Strong communication and organizational skills
Excellent understanding of GMP, GLP, GCP and GCLP expectations
Knowledge of global regulatory expectations (including FDA and EMA)
Preferred Requirements :
The established recognition within QA as a technical expert.
Demonstrated success in leading investigations and problem resolution.
Demonstrated success leading a team and training junior staff.
Demonstrated interest and ability to manage technical, operational, and administrative aspects of the team.
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas.
The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context.
The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond.
The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality.
The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues.
The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit.
This position may require periodic evening and/or weekend work
RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
RCMTechnologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.
Posting ID: 573195571Posted: 2020-09-29