Quality Control - Manager, Microbiology

The Quality Control Manager - 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. Candidates for this position must have experience in Microbiology (Product Testing, Environmental Monitoring and Utility Monitoring) 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 Manager (Microbiology) candidate will also be involved in method verifications, 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 Director and Associate Directors candidate will provide guidance to other groups within the QC organization.

External US

Essential Functions

• Generate staff shift and schedules aligned with required QC and manufacturing support functions.
• Provide clear and understandable direction and goals to supervisors and immediate team as applicable.
• 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/UM program, an author/review trend report for all FDBT facilities.
• Establish, monitor, and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed in collaboration with extended manufacturing and QA team.
• Investigate and trend invalid and out-of-specification results.
• Make critical decisions concerning analytical results (raw material, microbiology, EM/UM).
• Assure the implementation of appropriate and timely corrective actions.
• Work closely with Quality Assurance and other departments 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 including regulatory audits.
• Evaluate external audit observations and develop responses and oversight for related action plans.
• 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.
• 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.
• Demonstrated knowledge base in USP 61/USP 62/USP 85/ USP 71/ USP 787 / USP 788/ USP 789 for microbiological product testing.
• Familiar with qualification and classification of cleanrooms and performing risk assessments for selection of sites during validation activities.
• Oversight of water systems/compressed gas systems for qualifications and routine sampling
• Oversight of Microbial Identifications using different techniques.
• Maintain the safety and orderliness of the lab; apply knowledge of cGMPs and GLPs on daily basis.
• Perform training on laboratory methods and instrumentation.
• Perform other duties as assigned.

Required Skills & Abilities

• 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.
• Detail oriented and accurate.
• Ability to multi-task and prioritize work assignments.
• 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 Biochemistry, Biology, Biotechnology, Microbiology or similar education/experience and 9 years' experience; OR
• Master's degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education/experience and 8 years' experience.
• 4 years of direct management or supervisory experience
• GLP / GMP knowledge