*We are Kelly Science and Clinical**, *the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a Global contract development and manufacturing organization dedicated to the advancement and manufacturing of gene and cell therapy products, Constantly pushing the boundaries of what is possible, and providing future miracles to patients. For over 20 years, our client has served more than 180 clients with outstanding quality and reliability.
*Job Title:** QC Microbiology Supervisor - 2nd Shift*
The Supervisor, QC Microbiology organizes, and directs staff to meet and exceed cGMP requirements, establish KPI's, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance at the Allendale, NJ site.
*Responsibilities may include (but are not limited to) the following:*
* Investigate and document non-confirming events and environmental excursions.
* Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals.
Interact with other the EM/Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures, and processes between the sites.
* Participate in department and cross functional meetings.
Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
* Author and revise Standard Operating Procedures, Work Instructions, forms, and Protocols to reflect current practices.
* Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental Monitoring trending reports.
Provide staff development through feedback aimed towards performance development and review.
* Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
* Interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.
* Legally authorized to work in the job posting Country.
* Bachelor's degree in Microbiology or relevant field required.
* Biotechnology Certificate and/or cGMP experience
* Minimum of 3 years of experience with environmental monitoring or within the biopharmaceutical industry.
* Strong knowledge of microbiological test methods, philosophies, method validation and method transfer.
* Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
* Proficient with computer software with MS Office, Excel, and MODA.
* Adapts to changing business needs, conditions, and works with variety of situations, individuals, groups, and varying client needs.
* Ability to remain focused and effective in high stress situations.
* Builds constructive working relationships characterized by a high level of acceptance, cooperation, and mutual respect.
*Working Environment/Physical requirements:*
* *Second Shift Hours: 3:00 p.m.-11:30 p.m. (Monday-Friday)*
* Prepared to work within a professional office environment of a manufacturing operations plant.
* Noise level is moderate.
* Utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
* Ability to work in the cleanroom environment for extended periods.
* Skilled in working with specialized equipment.
* An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects
Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear.
* The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance).
*Generous Compensation and Benefits Package Including Relocation Assistance*
* "EOE, including Disability/Vets"*
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of [benefits](https://www.mykelly.us/us-mykelly/perks/)?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. [Equal Employment Opportunity is The Law.](https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)