CollegeStationRecruiter Since 2001
the smart solution for College Station jobs

Quality Control Supervisor - Microbiology

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021

Job Description:

Overview Summary: The Quality Control Supervisor - Microbiology under general direction, will be required to plan, organize, direct and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with The Company Quality and various regulatory requirements. In addition, the QC Supervisor will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory. Candidates for this position must have experience in Microbiology and Environmental Monitoring (EM) in a regulated pharmaceutical setting. Strong candidates will have a working knowledge of additional QC functions in a regulated pharmaceutical setting.Other responsibilities may include but are not limited to staff hiring, supervision, coaching, discipline and performing annual review assessments. Duties include reviewing data and problem solving in support of microbiological analysis. Additional responsibilities may include supervision of specified chemical or biological testing.The Quality Control Supervisor (Microbiology) candidate will also be involved in method development, method validation, method transfer and routine testing for incoming, in-process, release and stability testing on finished product, critical reagents and raw materials, as needed. In the absence of other supervisory staff they will provide guidance to other groups within the QC organization.External US Essential Functions:* Generate staff shift and analytical testing schedules aligned with required QC analytical manufacturing support functions. * Provide clear and understandable direction and goals for team.* Interpret applicable quality and regulatory requirements and develop associated policies for the laboratories operations.* Manage operating costs for the outsourced testing and laboratory supplies.* Develop and enhance the Company EM program. Establish, monitor and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed.* Investigate and trend invalid and out-of-specification results.* Make critical decisions concerning analytical results (raw material, microbiology, EM).* Assure the implementation of appropriate and timely corrective actions.* Work closely with Quality Assurance and other department to continuously improve the effectiveness of the Quality Management Team. * Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.* Interface with current and potential clients.* Interface with investigators during both internal and external inspections.* Evaluate external audit observations and develop responses and oversight for related action plans.* Support the QC documentation and data trending activities.* Function as lead for method transfer, qualification or validation projects, as applicable.* Adapt, develop, or review and approve procedures, protocols and reports.* Follow all established laboratory, regulatory, safety, and environmental procedures. * Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs.* Perform routine data entry and data trend analysis reports.* Identify deviations and report possible preventative and corrective actions.* Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of-Specification and failure investigations.* Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on a daily basis.* Perform other duties as assigned.* Perform training on laboratory methods and instrumentation. * Perform environmental monitoring* Other duties as assigned. Required Skills & Abilities:* Perform area cleaning, as needed.* Follow proper safety measures and policies while working in the lab.* Develop staff to maximize contributions to team and company.* Must have excellent organizational, written communications and oral communication skills.* Perform training on laboratory methods and instrumentation. * Ability to explain information appropriately based on the audience (i.e. technical concepts to a non-technical audience).* Ability to follow safety procedures outlined in the Chemical Hygiene Plan.* Computer proficiency required.* Excellent written and oral communication skills.* Excellent organization and analytical skills.* Detail oriented and accurate.* Ability to multi-task and prioritize work assignments with little supervision.* Knowledge of MS Office (Word, Excel, Outlook, PowerPoint).Working Conditions & Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:* Experience prolonged standing, some bending, stooping, and stretching.* Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.* Ability to sit for long periods to work on a computer.* Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.* Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.* Must be willing to work flexible hours.* Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.* Ability to work weekends and off-shift hours, as needed to support manufacturing activities.* Must be willing to travel occasionally, as needed.* Attendance is mandatory.Qualifications:* Bachelor's degree in Chemistry, Biochemistry, Biotechnology, Food Science, Biological, Chemical Engineering or similar education/experience and 5 years' industry experience in a GMP / GxP or a comparable federally regulated environment; OR* Master's degree in Chemistry, Biochemistry, Biotechnology, Food Science, Biological Engineering, Chemical Engineering or similar education/experience and 4 years' industry experience in a GMP / GxP or a comparable federally regulated environment* Previous supervising experience or demonstrated skills to lead and mentor a group cohesively, effectively and with compliance.We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.

Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Supervisor - Microbiology, Other , College Station, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Travel ICU RN / Crisis COVID-19 - Intensive Care Unit
Description: Intensive Care Unit RN - Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for (more...)
Company: HealthCare Traveler Jobs
Location: Pflugerville
Posted on: 01/16/2021

PACU RN Travel Nurse
Description: Nationwide Travel Nurse Jobs - Pre-Op / Post-Op RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: HealthCare Travelers
Location: Georgetown
Posted on: 01/16/2021

Nursery RN Travel Nurse Assignments
Description: Newborn Nursery RN - Nationwide Travel Nurse Jobs Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: HealthCare Traveler Jobs
Location: Pflugerville
Posted on: 01/16/2021


Intensive Care Burn Unit RN - Travel Assignments
Description: Intensive Care Burn Unit RN - Nationwide Travel Nurse AssignmentsAre you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking (more...)
Company: HealthCare Traveler Jobs
Location: Pflugerville
Posted on: 01/16/2021

Favor-Delivery-Driver (No Experience Needed & Flexible)
Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while
Company: Favor
Location: Pflugerville
Posted on: 01/16/2021

Crew
Description: The Crewmember - At Raising Cane's, What We Do is serve the Perfect Box, Fast, Friendly, Clean Have Fun A Crewmember has the primary responsibility of providing a positive Customer experience, including (more...)
Company: Raising Cane's
Location: Pflugerville
Posted on: 01/16/2021

Licensed Automotive Inspector
Description: Geared for the Driven br br Safety is always top of mind for Valvoline Instant Oil ChangeSM VIOC , and we want you to know that we are working hard to protect our team members and our guests with (more...)
Company: Valvoline Instant Oil Change
Location: Pflugerville
Posted on: 01/16/2021

Automotive Detailer Overnight
Description: 7154 - Austin - 13300 North I-35 Service Road South, Austin, Texas, 78753CarMax, the way your career should be When our vehicles shine, you will shineCarMax customers expect to choose from a range of (more...)
Company: CarMax
Location: Georgetown
Posted on: 01/16/2021

OR RN Travel Nurse - General, CVOR & Outpatient Surgery
Description: Travel Surgery Nurses Needed - Circulators Scrub Nurses br Nationwide Travel RN Nursing AssignmentsGeneral, Cardiovascular Outpatient Surgery experience br Looking for a Surgical Services travel (more...)
Company: RN Travel HealthCare Jobs
Location: Pflugerville
Posted on: 01/16/2021

Runner/Delivery Driver
Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while
Company: Favor
Location: Pflugerville
Posted on: 01/16/2021

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

College Station RSS job feeds