Quality Control Manager
This person will report to the Director of QC/AD. Responsible for all facets of managing the QC department at Stemedica. Oversee Environmental Monitoring and Biology Testing Programs. Responsible for interpreting regulations and ensuring compliance to departmental policies and procedures. Manage multiple quality systems and lead QC system improvement projects. Manage and develop QC personnel. Perform high level QC data analysis and serve as technical resource for the QC department. Interface with Manufacturing, Facilities and Quality Assurance leadership and participate/lead interdepartmental teams to address quality-related issues.
Essential Duties & Responsibilities:
· Participating in the development, implementation, enhancement and maintenance of QC systems.
- Evaluating QC systems and recommending and/or implementing system improvements.
- Conducting laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.
- Oversee the Environmental Monitoring Program, reviewing EM data, EM excursion investigations and EM reports.
- Oversee the Biology Testing Program, scheduling testing, reviewing biology data, investigate OOS and OOT results.
· Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.
- Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).
- Developing effective partnerships with other departments to facilitate problem solving and resolution of issues.
- Writing/revising test methods and SOPs. Writing and reviewing QC technical protocols and reports.
- Manage QC files and Environmental Monitoring electronic databases.
- Evaluate electronic database systems for implementation into QC.
- Excellent critical thinking and technical writing skills.
- Excellent interpersonal and communication skills and be able to lead and follow
- Ability to work effectively and efficiently on independent tasks as well as to accept direction on given assignments or in a team environment.
- Must have the following personal attributes: personal accountability, work ethic, sound judgment, strong organization skills, and attention to detail, eagerness to learn and continuously improve, systematic approach, and a dedication to quality.
- Must behave professionally and have respect for individuals and the diverse contributions of all.
- Computer skills required to operate Microsoft Word, Project, Visio and Excel programs.
- This person has direct reports and responsible for regular 1:1 meetings, performance/coaching/counseling as required, career development, time sheet management and annual performance reviews.
Education and Experience:
· B.S. or B.A. in microbiology or related field.
· At least 10 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
- At least 3 years of management experience is required.
· 5 years Environmental Monitoring experience is required.
- Method validation experience is a plus.
- Demonstrated ability to apply comprehensive understanding of QC guidelines, regulations, and current industry practices, including cGMPs and aseptic processing guidelines.
- GMP instrument qualification/validation experience is a plus.
· Cell Therapy experience is preferred.
· Must be able to work aseptically in controlled environments requiring special gowning (i.e. over the head, face, hands, feet and body).
· No make-up, nail polish or artificial fingernails may be worn in the work environment.
· Must be able to work in a moderately noisy environment.
· Must be able to work around bio-hazardous materials and chemicals such as alcohol, acids, and /or buffers.
- Must be able to lift, push, pull and/or carry 25 lbs.
- Must be able to use hands and fingers to handle and feel objects, tools and controls.
- Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.
- Must be able to successfully pass routine gowning and aseptic qualifications.
- Must be able to work in aseptic areas and in compliance with 21 C.F.R. 211.28 (b), a copy of which is attached.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the job. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.