QC Microbiology Supervisor

Company: Germer International
Location: Rockville
Posted on: September 13, 2020

Job Description:

The Quality Control Supervisor, Microbiology is responsible for overseeing the daily operations of the microbiology and environmental monitoring testing programs at the company to ensure compliance with cGMP standards. This position will directly supervise a team of QC analysts, and will interact extensively with other department supervisors, quality personnel, manufacturing personnel, and business partners. This person will also be responsible for development, transfer and validation of microbial test methods.

Responsibilities:

Oversees the work of QC analysts that contribute to the Supervisor’s area(s) of functional responsibility, ensuring all work is completed properly and in a timely manner. Provides input and feedback to other supervisors for ongoing development of employees and towards annual performance assessments.

Provides direct supervision of one or more junior level QC analysts, assuming primary responsibility for communication of requirements and expectations of the employee’s daily job. Will perform all aspects of a supervisor’s role including hiring, coaching, developing, providing regular feedback to employee about his/her performance, and managing performance or behavioral deficiencies.

Manages Microbiology (Environmental Monitoring and utilities) related sampling and testing of in-process and lot release samples. Functional area oversight requires assuring that relevant deliverables are provided on time to support corporate, CMC, and departmental goals. Will also be responsible for assuring that analysts are trained on the relevant equipment and methodology, assuring equipment is maintained and used properly, providing first line troubleshooting as needed, and reviewing related Quality event records (e.g., Deviations and CAPAs).

Assists in designing and continuously improving Quality Control systems, particularly within areas of microbiology.

Writes and reviews departmental and interdepartmental SOPs covering microbial methods and general policies.

Reviews, analyzes and trends microbial data that may include EM, in-process, lot release, and/or stability related microbial testing. Regularly review failure trend data within assigned functional area, and be responsible for investigation of out of trend situations.

Responsible for developing, establishing, transferring, and validating microbial testing methodology.

Qualifications:

Education, Experience, & Credentials

High School Diploma and minimum of 10 years of direct related experience, plus minimum of 2 years of supervisory experience.

Bachelor’s Degree in a scientific discipline and minimum of 6 years of experience, plus at least 2 years prior experience coaching and mentoring junior level laboratory personnel.

Significant experience in a GMP or GLP testing environment.

Prior experience providing oversight of a cleanroom microbial area of expertise, such as environmental monitoring or utilities monitoring group.

Experience working on extremely complex problems in which analysis of situation or data requires an in?depth evaluation of intangible variables.

Knowledge, Skills and Abilities

Ability to act independently to determine schedules, methods and procedures on new assignments

Possesses the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results

Able to handle multiple priorities in a fast-paced environment

Excellent written and verbal communications skills

Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise

Broad knowledge base of cGMP requirements for quality control testing

Flexibility and adaptability to facilitate the movement into different areas of QC

Proficient in the use of Microsoft or equivalent software; word processing, email, spreadsheet or other analysis tools, database, and Internet

Supervisory Responsibilities:

Will directly supervise the activities of 2-5 lower-level personnel

In over 25 years of placing the right professionals in the right jobs, Germer International has earned the trust of hundreds of Pharmaceutical, Biotech, and Medical Device companies, attracting the best qualified candidates.

VEVA 14

1777 Sentry Parkway | Blue Bell PA 19422

Keywords: Germer International, Rockville , QC Microbiology Supervisor, Other , Rockville, Maryland