Quality Control Supervisor - Microbiology
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.
- 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.
- 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.