QA Microbiologist II

　　Allentown, PA

　　Direct Hire

　　Full Time

　　2 nd Shift (2:30P-10:30P), Monday-Friday

　　Compensation: $70,000-$80,000/yr (flexible depending on experience)

　　Kelly Science & Clinical is looking for a QA Microbiologist II support a global medical and pharmaceutical device client in Allentown, PA.

　　RESPONSIBILITIES

　　Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost-effective way.

　　Direct responsible for the supervision test operation at all times for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory 00S result.

　　Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.

　　Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.

　　Participates in projects, task force jointly with production personnel in case the needs arise.

　　Prepares trend analysis and data compilation on deviation in the production process when required.

　　Participates in internal and external audit.

　　Participates in the Global Microbiology Task Team, whenever required.

　　Responsible in microbiological release of medical devices or Pharma products and Pharma incoming materials.

　　Supports microbiological tasks for process validation.

　　Trains and proactively develops the education standard of the responsible persons.

　　Quality, technical data review and investigation oversight.

　　Collaborate with all departments and reports metrics to site management to continuously drive quality improvements.

　　KNOWLEDGE & SKILLS

　　Familiar with Data Integrity and GDP in a cGMP Laboratory environment.

　　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.

　　Requires full working knowledge of relevant business practices and procedures in professional field.

　　Uses standard theories, principles and concepts and integrates them to propose a course­ of action.

　　Works under general supervision.

　　Relies on experience and judgement to plan and accomplish assigned goals.

　　May periodically assist in orienting, training, and/or reviewing the work of other peers.

　　Judgement is required in resolving complex problems based on experience.

　　Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

　　cGMP experience/training required, Aseptic processing training/experience required

　　QUALIFICATIONS

　　Bachelors degree required, Master's degree preferred.

　　04-06 years related experience required.

　　Proven and/or demonstrated skills/abilities in leadership, educational training and/or experience will be taken into consideration.

　　Previous supervisory experience.

　　cGMP experience/training required, Aseptic processing training/experience required

　　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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.