Scientist II, QC Microbiology - 1917033
Lakewood, NJ, 08701, US
Salary: 85000k/year - 88000k/year
Reference ID: 1917033
Date Posted: 04/10/2024
Shortcut: http://shurig-solutions-inc.jobs.mrinetwork.com/JJG0E7
Job Title: Scientist II, QC Microbiology - 3rd shift
Location: US-NJ
Overview:
The Scientist II, Microbiology will test and report cGMP test results for the Quality Control Microbiology Laboratory. This role also provides training and support for less experienced members of the laboratory.
Shift: 3rd shift, Sunday-Thursday 11:00 pm - 7:30 am
Responsibilities:
• Follows current GMP requirements and complies with company safety and controlled substance handling policies.
• Participates in the repair and maintenance of lab equipment and lab housekeeping (disinfection and cleaning).
• Initiates, documents and performs microbiological analysis on received test samples (including raw materials, bulk, final product, stability, water) as per USP, in-house or customer methods. Evaluates, records, and reports data under minimal supervision.
• Performs environmental monitoring, as required; Evaluates, records, and reports data.
• Performs quality control testing of media, reagents, and identification materials.
• Maintains adequate inventory of media and materials required for testing.
• Initiates proper documentation upon discovery of deviations and out-of-specification results, completes Trackwise write-up for deviations and out-of-specification results.
• Performs special projects as assigned including testing, compiling and trending of data and report generation.
• Performs data entry for tracking and generates trend analysis reports for EM program, etc.
• Revises SOPs, forms, protocols, and other controlled documents.
• Performs micro-identifications using manual testing and automated systems.
• Maintains lab stock cultures for evaluative testing and make dilutions of stock cultures as required by procedure, protocol, or USP requirements.
• Maintains intradepartmental communication to support company goals.
• Reviews laboratory logbooks to ensure compliance with good documentation practices.
• Releases manufacturing areas after recovery using the ASCN in Trackwise. Writes Trackwise notifications and deviations and completes CAPAs. Creates and completes Trackwise change controls. Writes and revises SOPs, forms, risk assessments and other controlled documents.
• Interact with Operations staff to facilitate data and documentation corrections. Interacts routinely with departments such as Production, Quality Assurance and Regulatory Affairs.
• Creates purchase orders as needed.
• Flexibility in schedule is required.
Qualifications:
Bachelor’s degree in biology, health science or microbiology.
2-5 years’ experience in cGMP micro expertise.
-
Senior Scientist - 1941739
Lakewood, NJ, 08701, US
Job Title: Senior Scientist Location: US-NJ Overview: The Sr. Scientist leads formulation development of new pharmaceutical products through formulation optimization, product development and scale-up activities. Applying a solid understanding of theori...
Date Posted: 04/22/2024 Recommended
-
MSAT Scientist III - 1966256
Lakewood, NJ, 08701, US
Job Title: MS&T Scientist III Location: US-NJ Overview: The purpose of this position is to support the Company in the development and optimization of manufacturing processes, improving them and increasing the scale. The ultimate goal is to develop proc...
Date Posted: 04/29/2024 Recommended
-
Process Engineer II/III - 1917023
Lakewood, NJ, 08701, US
Job Title: Process Engineer II Location: US-NJ-Lakewood Overview: Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production...
Date Posted: 04/10/2024 Recommended
-
Senior Validation Engineer - 1917039
Lakewood, NJ, 08701, US
Job Title: Sr. Validation Engineer, Equipment & Sterilization Location: US-NJ Overview: This position is responsible for Equipment and Sterilization Validation processes (i.e. including but not limited to Autoclave, SIP, tunnel, dry heat, and VHP studi...
Date Posted: 04/10/2024 Recommended
-
Corporate Controller - 1910842
Lakewood, NJ, 08701, US
Job Title: Corporate Controller Location: US-NJ Overview: The Corporate Controller directs and has immediate responsibility for the organization’s overall accounting practices, the maintenance of its fiscal records, and the preparation of its financial...
Date Posted: 04/09/2024 Recommended
-
Senior Global Product Manager - 1927797
Princeton, NJ, 08540, US
Senior Global Product Manager Product Category- Surgical Reconstruction, TT Location- New Jersey ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Manages n...
Date Posted: 04/15/2024 Recommended
-
Senior Manager Of Validation - 1910894
Lakewood, NJ, 08701, US
Job Title: Sr. Manager, Validation Location: US-NJ Overview: This position is responsible for Validation activities (i.e. including but not limited to Manufacturing and packaging equipment qualification, Process validation activities, and Cleaning and ...
Date Posted: 04/09/2024 Recommended
-
SSIATDP01 - Demand Planner
Lakewood, NJ, 08701, US
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in...
Date Posted: 11/08/2023 Recommended
-
SSIMRICSA01 - Scientific Advisor
Lakewood, NJ, 08701, US
Duties: General Description: As a member of the organization, the Scientific Advisor will support regional strategies and establish compliant relationships with opinion leaders, research collaborators and key organizations in support of the BeiGene pip...
Date Posted: 01/23/2024 Recommended
-
Senior Staff Electrical Engineer - 1909288
Portage, MI, US
Our Partner is a top 20 global medical device company with a culture of promoting from within while allowing vertical or horizontal career growth. Location: Portage, MI – Hybrid, 3 - 4 days a week in the office – Relocation assistance provided Sponsors...
Date Posted: 04/05/2024 Recommended
-
Operational Excellence Engineer - 1916706
Lakewood, NJ, 08701, US
Job Title: Operational Excellence Engineer II Location: US-NJ-Lakewood Overview: The Operational Excellence Quality Engineer II will be responsible for driving business transformation through the implementation of Operational Excellence tools and cultu...
Date Posted: 04/09/2024 Recommended
-
Process Mechanic - 1966634
Lakewood, NJ, 08701, US
Process Mechanic, Off Shift Job Locations US-NJ-Lakewood The Process Mechanic will perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA...
Date Posted: 04/29/2024 Recommended