Quality Control Scientist - Microbiology

Introduction

Quality and safety above everything . That is the unassailable theme that guides everything that we do, every day. We have an unwavering commitment to quality and the production of safe and effective products.

Our science and risk-based compliant quality culture is innovative and healthcare oriented. Whether you are involved in development, operations, maintenance, compliance or analysis, through research and manufacturing programs, your contribution will directly impact our success.

Your Diligence Means Our Success

At Pherros Biosciences, we combine development and safety to improve the lives of those around us. Our employees bring life-changing medicines to people in need and improve the understanding and management of disease.

We give our best to putting people first and we are looking for people who are determined to improving life for everyone.

You will be a member of Pherros Biosciences’ dedicated and highly effective quality control operations team. Our aseptic manufacturing facility for parenteral pharmaceuticals presents an exciting opportunity to be an important part of a state-of-the-art facility and quality system.

The Quality Control Laboratory assures patients worldwide that our drug products are safe and effective and of the highest quality and integrity.

We exceed these standards through effective execution of process, environmental, supply and product testing.

General Requirements

A Quality Control Laboratory Microbiologist performs accurate and timely testing of routine and non-routine samples in accordance with appropriate Good Manufacturing Practices ( GMP ), Good Laboratory Practices ( GLP ), and safety guidelines, to support site production and stability requirements.

The Quality Control Scientist will perform laboratory testing techniques including but not limited to Bioburden Analysis, Endotoxin, Sterility, Growth Promotion, Particulate Matter Analysis, Container Closure Integrity Testing ( CCIT ), Microbial Identification, Aseptic Process Simulation ( APS ), Visual Inspection, training of Environmental Monitoring ( EM ) Technicians and oversight of EM results.

The Quality Control Scientist will review and interpret results and will perform second person verification ( SPV ) of analytical data.

The Quality Control Scientist utilizes technical skills to perform in-depth problem solving, to proactively identify opportunities for continuous improvement, and to assist in resolving laboratory investigations of atypical data and results.

Additional key objectives and deliverables include the capability to :

• Accurately and safely perform timely testing of routine and non-routine lab samples in accordance with appropriate GMP, GLP, and safety guidelines.
• Accurately record data in reports or Laboratory Information Management System ( LIMS ) in accordance with laboratory procedures, Good Laboratory Practices ( GLP ), standards, and GMP requirements.
• Recognize deviations from procedures, methods, etc., and initiates an investigation as required.
• Verify analytical data generated by other analysts within the lab as required.
• Adhere to all Environmental, Health, and Safety ( EH&S ) standards.
• Identify and communicate opportunities for improvement initiatives in daily work activities.
• Troubleshoot equipment and methods as required.
• Provide technical support for non-routine (e.g., deviation) investigations.
• Maintain inventory of all supplies and consumables for the laboratory.
• Gown for activities within aseptic manufacturing suites typical of a GMP environment.
• Engage in training exercises to fulfill compliance requirements associated with the position.

Educational, Experience and Training Requirements

Bachelors (4-year college) (or higher level) degree in Microbiology, Biochemistry, or Biology with three (3) to five (5) years of relevant experience in a GMP Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring.

Candidate should also have knowledge of and familiarity with Good Documentation Practices associated with GMP processes, strong organizational, record-keeping, time management, project management and written and verbal communications skills.

Additional Preferences :

Experience with a LIMS system.

Experience with a Quality Management System ( QMS ) such as Master Control.

Experience performing Bioburden, Endotoxin Testing, Sterility, Growth Promotion, Biological Particulate Matter Testing, Container Closure Integrity Testing, and Identification Techniques.

Demonstrated problem solving and analytical thinking skills.

Understanding of statistical tools and analysis.

Excellent interpersonal skills and networking skills.

Experience in a GMP QC Lab environment.

Demonstrated written and verbal communications skills.

Strong attention to detail.

Ability to organize and prioritize multiple tasks.

Experience with Root Cause Analysis.

Demonstrated ability to work both independently and as a part of a team.

Additional Information

The position is full-time non-remote, Monday through Friday, with flexibility to support weekends on occasion. Applicants will work in various areas within the site.

Some allergens may be present in the facility. Exposure to allergens should be considered when applying for this position.

Tasks may require repetitive motion (e.g., keyboarding).

Minimal travel required.

Sunshine Act

Pherros Biosciences reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.

These laws and regulations require Pherros Biosciences to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.

Subject to further legal review and statutory or regulatory clarification, which Pherros Biosciences intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.

Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pherros Biosciences that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.

If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pherros Biosciences is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Pherros Biosciences also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Quality Control

About Us

Careers at Pherros Biosciences are like no other. We believe in our ability to improve future healthcare, and potential to transform millions of lives.

We’re looking for new talent to join our global community in order to bring innovative therapies to market and to make the world a healthier place.