- Assure testing priorities to support Manufacturing and Customer Service
- Establishes and implements appropriate training programs for the sites to provide micro awareness and coaching.
- Performs regular GEMBA style assessments of the sites and performs routine audits of the manufacturing areas.
- Ensure data integrity and ensure GDP and GLP in the microbiology laboratory.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity, ability to recognize time sensitivity.
- Demonstrates strong knowledge of cGMP, ICH, FDA and compendial (USP, EP, JP) guidance.
- Strong knowledge of microbiological test methodology, environmental monitoring and industry standard investigation process of any OOS that are related to microbial contamination.
- Reviews and provides oversight for microbial testing performed at contract labs.
- Extremely detail-oriented with strong analytical, verbal, and written communication skills.
- High level of ownership and accountability with strong ability of problem solving
- Ensure test failures are investigated and documented as per regulatory guidance.
- Ensure implementation of effective CAPA based on root cause analysis.
- Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
- Resolve test method issues which many involve interaction with customer and provide expert opinion
- Evaluate time and cost aspects of laboratory work associated with new product launce or new testing requirements.
- Provide microbiological technical support to validation projects.
- Ensure calibrations of lab equipment, documentation in logbooks and other GMP compliance activities are performed in the laboratory.
- Develop and implement ways to improve laboratory productivity, cost control and output.
- Review and approve SOP's, specifications, and other documentation required to administer the laboratory.
- Perform other duties as assigned.
- Experience in pharmaceutical product testing / Microbiology.
- Knowledge and experience with Total Quality Management and other quality management philosophies.
- Thorough understanding of Compendial test methodology applicable to microbiology.
- Fluency in written and spoken English
- Familiarity with LIMS and TrackWise
- Ability to use computer applications like Microsoft Outlook, Excel etc
- Ability to manage many diverse tasks and issues simultaneously, through prioritization, delegation, and "hands-on" personal effort in a fast paced, high-volume environment.
- Understanding of laboratory safety requirements and the MSDS system.
- Ability to read, comprehend, and interpret technical data.
- Ability to represent Accupac to customers and regulatory agencies.
- Sitting for % of the work day.
- Walking/standing up to six hours each work day.
- Hear/Execute clear speech, in person and over the telephone.
- Lift/Carry items up to 40 pounds.
- Hear phones ring, alarms sound through ambient noise and everyday conversation.
- Possess color vision.
-
Manager - Microbiology Lab
1 week ago
Accupac Harleysville, United StatesAccupac is hiring for a full-time Microbiology Lab Manager to join our Mainland PA. team. · Job Summary: · The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologists. ...
-
Manager - Microbiology Lab
6 days ago
Accupac Harleysville, United StatesAccupac is hiring for a full-time Microbiology Lab Manager to join our Mainland PA. team. · Job Summary: · The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologist ...
-
Part-Time Microbiology Lab Faculty
2 weeks ago
Montgomery County Community College Blue Bell, United States Part timeReports to: Dean of Science, Technology, Engineering and Mathematics · Probationary Per Credit Rate: $1,360.03. · *This position requires the candidate to obtain the PA Child Abuse, PA State Police, and FBI Fingerprinting clearances prior to their start dat e. · GENERAL DESCRI ...
-
Microbiology Lab Technician
6 days ago
SURE BIO-CHEM LABORATORIES LLC Camden, United StatesJob Description · Job DescriptionWho Are We? · Sure-BioChem Laboratories is a leading analytical testing service, known for delivering high-quality and accurate testing for many industries. · The mission of Sure-BioChem Laboratories is to provide the highest quality microbiologic ...
-
Senior Scientist
2 weeks ago
Insight Global Lansdale, United StatesEducation Minimum Requirement: · B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or · Master's degree with 4+ years of relevant experience; or Ph.D. with ...
-
Senior Scientist
2 weeks ago
Insight Global Lansdale, United StatesMust Haves: · B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field · 6+ years experience within vaccine development · Experience with small, lab, or pilot scale microbial large molecule fermentation ...
-
Assistant Scientist
3 days ago
MassGenics Lansdale, United States ContractJob Description: We currently have an opportunity for a scientist to join our team in Varicella bulk vaccine manufacturing, within the Merck Manufacturing Division (MMD), supporting a new PAT (process analytical technology) lab and laboratory operations. A successful candidate mu ...
-
Scientist - I (Assistant) - PA/NJ Only
1 week ago
ACS Group Lansdale, United StatesJob Description · Job Description: We currently have an opportunity for a scientist to join our team in Varicella bulk vaccine manufacturing, within the Merck Manufacturing Division (MMD), supporting a new PAT (process analytical technology) lab and laboratory operations. A succe ...
-
Scientist
3 weeks ago
Collabera West Point, United StatesHome · Search Jobs · Job Description · Scientist · Contract: West Point, Pennsylvania, US · Salary: $25.00 Per Hour · Job Code: 348913 · End Date: · Days Left: 28 days, 3 hours left · Apply · About the Role: We are seeking a Scientist I (Assistant) to join our team in Varicell ...
-
Food Microbiologist
3 weeks ago
Godshall's Quality Meats, Inc. Souderton, United StatesPay starting at $22 based on experience. · **Duties and Responsibilities** · Primary job duties and responsibilities include: · - Conduct experimentation using a designed approach to validate formulations and processes at the bench and pilot scale before entering production. · - ...
-
Associate Scientist
1 month ago
American Cybersystems, Inc. Lansdale, United StatesJob Description: We currently have an opportunity for a scientist to join our team in Varicella bulk vaccine manufacturing, within the Merck Manufacturing Division (MMD), supporting a new PAT (process analytical technology) lab and laboratory operations. A successful candidate mu ...
-
Associate Microbiologist
1 day ago
Eurofins USA Food Testing Horsham, United States Full timeJob Description · Responsibilities: · Performs microbiological testing of raw material, finished product samples and purified water · Perform and document all test data in accordance with cGMPs and company SOPs. · Perform plate reading and result calculations for samples analyze ...
-
field calibration technician ii
2 weeks ago
QUANTUS INC Blue Bell, United StatesJob Description · Job DescriptionDescription:Company Description At Quantus, Inc., a Pennsylvania-based corporation, we specialize in Life Sciences Equipment Services. Our work spans across onsite: Asset & Reliability Management, Calibration, Certification, Microbial Environmenta ...
-
field calibration technician i
2 weeks ago
QUANTUS INC Blue Bell, United StatesJob Description · Job DescriptionDescription:Company Description: At Quantus, Inc., a Pennsylvania-based corporation, we specialize in Life Sciences Equipment Services. Our work spans across onsite: Asset & Reliability Management, Calibration, Certification, Microbial Environment ...
-
Medical Lab Scientist
3 weeks ago
ALOIS Healthcare Pottstown, United StatesJob Title: Medical Lab Scientist · Location: Pottstown, PA · Position Type: Permanent · Salary: Up to $79,976 + Benefits · Please know this is a Part Time position (40 hrs. per pay, approx. 20 hrs. per week). · Responsibilities: · Performs a wide range of moderate and high compl ...
-
Research Specialist A/Microbiologist
5 days ago
Trustees of University of Pennsylvania Philadelphia, United States Full timeDescription · Job Responsibilities: · The Research Specialist will have to following duties: · -- Experimental Execution: Conduct experiments using a range of techniques in microbiology, peptide design, bioinformatics, biophysics, cell/tissue culture, animal models, and chemica ...
-
Medical Technologist
2 weeks ago
Deborah Heart and Lung Center Burlington City, United StatesJob Details · Description · Position Summary: Performs routine and special diagnostics testing and lab procedures in various specialty sections of the Clinical Laboratory in a prompt, accurate and reliable manner according to established hospital and departmental policies and pro ...
-
Analytical Chemist
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Bristol, United StatesAnalytical Chemist · Bristol, PA · Full-Time · M-F, 1st Shift · 6mo contract (potential to extend) · Compensation: $31-38hr · Kelly is looking for an Analytical Chemist to work with our client who focuses on developing specialty additives that support the production and performan ...
-
InsideHigherEd Philadelphia, United States Faculty Jobs ,Colton Center for Autoimmunity- UPenn- Associate Professor or Full Professor Faculty Position · Location: · Philadelphia, PA · Open Date: · Oct 17, 2023 · Close Date: · Oct 17, 2025 · Description: · The Colton Center for Autoimmunity at the Perelman School of Medicine at the Univ ...
-
Medical Laboratory Scientist I
4 weeks ago
Mass General Brigham Northampton, United States RegularMedical Laboratory Scientist I Description Cooley Dickinson is the hospital where Medical Lab Technician's can grow and accelerate their careers. We are seeking professionals who are committed to the highest quality patient care and will contribute to our on-going pursuit of exc ...
Manager, Microbiology Lab - Mainland, United States - Accupac
Description
Job Description
Job DescriptionManager, Microbiology Lab, Full-TimeAccupac is hiring for a full-time Microbiology Lab Manager to join our Mainland PA. team.
Job Summary:
The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologists. This role is responsible for effectively collaborating with multiple stakeholders to ensure Industrial Plant Hygiene, establishing, and publishing periodic reports on environmental monitoring and trending. This role will also support new product launches by revieing product specification, test methodology and providing guidance in test method verification and validation.
The Manager, Microbiology will have strong leadership and substantial experience in supporting the sites to be complaint with regulatory requirements in microbial control standards and procedures. This position will also play a critical role as SME in assisting audits.
Essential Duties and Responsibilities include but are not limited to the following:
Minimum Requirements of the Job:
Physical Requirements:
Supervisory Responsibilities: Yes; Microbiologist
Travel: None
Education and/or Experience: Bachelor's degree in a relevant discipline (Microbiology preferred). Minimum of five years management experience in the pharmaceutical industry within a Quality Control microbiology role.
#INDOTHER2023
