Quality Control- Group Leader, General Protein Sciences
The incumbent plays a critical role in the growing Quality Control (QC) department, integrating managerial, technical and GMP activities. The group leader utilizes a matrix approach and a team philosophy to coordinate with other supervisors to achieve objectives and goals.
General Responsibilities may include:
?Coordinate, review, and summarize test results (including appropriate statistical applications).
?Execute analytical protocols and test methods as assigned.
?Critically review test reports and data (from internal and external sources) for compliance with GMPs and SOPs, scientific rationale, documentation, and conclusions. Coach as needed.
?Ensure timely disposition and reporting of drug substance and drug product test results according to published schedule.Specific for manufacturing testing group leader?
?Maintain currency and revisions to USP, ICH, CFRs and other guidance materials to ensure ongoing compliance.
?Mentor and facilitate the professional development of QC analysts.
?Represent QC department with internal stakeholders to ensure coordination of activities to achieve objectives.
?Department training per SOPs and internal initiatives.
?Other duties, as assigned.
Specific Responsibilities may include:
?Oversite of raw materials testing and reporting.
?Oversite of environmental monitroing testing and reporting.
?Ensure that release testing and reporting (including external test results) are properly performed and in a timely manner to meet requirements for relsase schedule
?Maintain lab logbooks.
?Ensure maintenance of lab equipment maintenance.
?Prepare test schedule using matrix approach in conjunction with Stability Group Leader .
?Ovesite of miscellaneous testing requests.
?Minimum BA/BS, preferably in a scientific discipline or equivalent.
?Experience in cGMP work environment.
?High skill level in the use of Microsoft Office programs including Word, Excel, and Power Point.
?Applied knowledge of statistics to biological product data. (Most relecant for the stability group leader)
?Ability to work both independently and constructively as directed and within project teams.
?Strong organizational skills, including the ability to prioritize workload
?Excellent American English verbal and written communication skills are essential.
?Strong interpersonal skills and the ability to interact effectively with a variety of personnel.including quality assurance, process development, and manufacturing staff.
?A minimum of 6 years experience in pharmaceutical/biotechnology industry or a combination of industry experience and graduate education in a scientific discipline.
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