Kelly Services
Location
Allentown, PA | United States
Job description
QC Microbiology Supervisor
Allentown, PA
Direct Hire
Full Time
1 st Shift, Monday-Friday
Compensation: $70,000-$80,000/yr (flexible depending on experience)
Kelly Science & Clinical is looking for a QC Microbiology Supervisor support a global medical and pharmaceutical device client in Allentown, PA.
RESPONSIBILITIES
Primary Functions:
Provides direct or indirect supervision to QCC and QT employees, assigning tasks and duties related to laboratory quality control within organization.
Ensures the efficient use of resources to achieve department quality and operation plan.
Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.
Responsible for employees’ relations actions including (but not limited to) hiring, performance management and termination recommendation.
Responsible for leading the team in completion of a variety of routine and non-routine tasks including writing investigation reports, deviations, protocols, updating procedures and other related documentation.
Routine Functions:
Leads root cause analysis and corrective/preventive actions for laboratory investigations and product complaints.
Ensures all laboratory equipment is validated, maintained, and calibrated according to cGMP’s and company requirements.
Plans and organizes microbiological testing activities within the lab: microbial identification, bioburden, sterility test, growth promotion, particulate matter, bacteriostasis & fungistasis, LAL Kinetic Turbidimetric / Gel-clot methods, and other testing for special studies.
Conducts visual and physical inspections of company products and materials.
Develops, implements, and assesses processes and policies designed to test products and services.
Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
Enforces regulatory compliance.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
KNOWLEDGE & SKILLS
Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
Judgement is required in resolving complex problems based on experience.
Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
Ability to analyze samples to determine Microbial enumeration methods, absence of specified microorganism and other testing analysis including environmental monitoring of production areas.
Devises and develops processes and methods for the solution of technical problems.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals.
May periodically assist in orienting, training, assigning, and checking the work of lower-level employees. Referring only complex problems and issues.
Familiar with Data Integrity and GDP in a Lab environment
QUALIFICATIONS
Bachelor's degree required.
04-06 years related experience required, 02+ years of leadership experience
Knowledge in areas such as Microbiology method validation/lab equipment requalification/aseptic fills is preferred.
Theoretical knowledge of subject matter, CGMP, FDA guidelines, GLP and USP’s. (Complete knowledge of good analytical and laboratory techniques, basic knowledge of cGMP’s, GLP’s, SOP’s, USP and FDA requirements).
Ability to learn new skills related to Environmental Monitoring and manage supporting documents derived from Facilities for HEPA Re-Certifications and etc.
Strong organizational and time management skills
Ability to manage and train team
Applicable industry/professional certification preferred.
Ability to work non-standard schedule as needed.
Regular and predictable attendance.
Occasional business travel required, Valid driver's license and passport
P#1
Send resumes to [email protected]
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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