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This position is responsible for administrative management and communications of all aspects of the AIR (Allston Integrated Remediation) Project that requires QC support. This position reports to the the Associate Director Quality Control Projects and includes following duties:
Review and approval of protocols and reports.
Serves as a subject matter expert (SME) for required change control and associated risk assessments, coordinates and manages project related samples and sample plans, and acts as the principal liaison between project leadership and the QC department.
Supports compliance with all applicable regulations and corporate standards.
Communicates resource and testing requirements to QC Management in a timely and planned manner so that adequate staffing and instrument capacity levels are available to meet project timelines.
Provides the AD QC Projects with key input, direction and leadership in support of complex QC challenges related to AIR project and objectives.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessments.
Actively partners and collaborates with key stake holders during project planning to ensure timely completion of QC project objectives and milestones consistent with site priorities and objectives.
Ensures timely escalation of issues impacting the project and QC to the AD QC Projectsand the Project team.
Tracks and reports QC operational readiness required to support the AIR Project using appropriate project management tools and dashboards.
Develops key project performance indicators that will drive laboratory deliverables for a given project.
Generally accomplishes results through others, management level and non-management level.
Specific Responsibilities include:
Represents QC at AIR Project meetings.
Provide QC expertise for change controls and report reviews.
Contributes along with QC management in decision making regarding protocols where QC has responsibilities.
Effective interaction in a cross-functional team environment (internal and external teams comprised of Quality groups, Manufacturing, MTS (Manufacturing Technical Support), Engineering, Materials Management, Validation, etc.
Experience with project management and statistical analysis
Experience working in a team environment, facilitating a team approach and communicating effectively
Personal computer operation with appropriate word processing, database, and Excel spreadsheet software
Strong understanding of Quality Systems
Proven management and leadership skills
Familiarity with Deviation Management Systems, Change Control Systems
Experience working with cross-functional teams, including Quality, Manufacturing, MTS, Facilities and Engineering.
Experienced in problem resolution, troubleshooting, investigation, root cause analysis, risk management in a CGMP environment.
Good working knowledge of laboratory information management systems (LIMS).
Experience in testing biologics
Bachelor of Science in Chemistry and/or Life Sciences field with 9 years laboratory experience in a pharmaceutical/biopharmaceutical environment
Master of Science in Chemistry or Life Sciences field with 6 years laboratory experience in a pharmaceutical/biopharmaceutal environment
Extended experience in a CGMP Facility
Knowledge of compendial requirements, ICH method validation principles, CGMP's/harmonized regulatory requirements, laboratory investigational tools and experience with presenting information to the FDA
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