QC Microbiology Analyst II, III
4 weeks ago
- Environmental monitoring in controlled environments; Non-viable particulate monitoring, Active viable air monitoring Personnel monitoring, Surface sampling, Passive air monitoring
- Equipment monitoring; Ensure equipment is in proper working conditions, Ensure all equipment is properly maintained/calibrated, Program equipment with proper workflows, Assist with routine laboratory testing, Plate reads and incubations
- Shipping of test samples and equipment to contract laboratories for testing
- Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Writing/conducting investigations pertaining to environmental monitoring and testing
- Develop and train QC Microbiology Analyst I personnel on relevant business processes
- BA/BS in a science or relevant field required or equivalent experience; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
- GxP/GDP, Safety Trained
- Proficient with computer software such as; Microsoft Office, MODA/LIMS
- Familiarity with ISO and EU standards
- Strong written and oral communication skills.
- Technical training ability.
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays, and as required by the company.
- Must be able to handle the standard/moderate noise of the manufacturing facility.
- The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period.
- Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.
- Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Coordinates data for batch release.
- Participation in project/client meetings and communications, providing scientific and technical expertise.
- Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols.
- Review of investigations and documentation of non-confirming events and environmental excursions.
- Apply expertise of compliance requirements to maintain an inspection-ready state.
- Participate and act as subject matter expert during audits/inspections.
- Develop and train QC Microbiology Analyst II on relevant business processes.
- Processing of purchase orders for outsourced testing and lab supplies.
- Coordinates work orders.
- BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry
- GxP/GDP Trained
- Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred)
- Proficient knowledge of ISO and EU standards
- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
- Strong written and oral communication skills
- Strong technical writing skills
- Technical training experience
- Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays and as required by the company
- Must be able to handle the standard/moderate noise of the manufacturing facility
- While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
- Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays, and as required by the company
- Must be able to handle the standard/moderate noise of the manufacturing facility
-
QC Microbiology Analist I, II, III
3 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I will perform environmental monitoring activities including, but not limited to, non-viable particulate testing,...
-
QC Microbiology Engineer(s) I, III
1 month ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not...
-
Quality Control Microbiology Engineer III
1 month ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical...
-
Quality Control Analytical Associate II
4 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production....
-
QC Manager, Training
1 month ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological...
-
Sr. Technical Trainer
2 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Analytical Sr. Technical TrainerAllendale, NJ The QC Senior Technical Trainer facilitates and conducts on-the-job training for QC personnel; for both the effective induction of new hires into QC, as well as, the ongoing improvement and proficiency (i.e. cross-training) of personnel within the department, by delivering...
-
Quality Control Manager
2 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob Description Job Description Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...
-
Quality Control Manager
4 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that...
-
Quality Assurance Associate III
2 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob Description Job Description Quality Assurance Associate III Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...
-
Quality Assurance Associate III
4 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal...
-
Quality Control Manager
4 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob Description Job Description Quality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...
-
Quality Control Manager
4 weeks ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily...
-
Quality Assurance Manager
1 month ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations...
-
Quality Control Analytical Supervisor
2 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities...
-
Qualtiy Control Compliance Investigator
1 month ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions,...
-
Manager I
4 weeks ago
Saddle Brook, United States kdcone, Chemaid Full timePosition: Manager I - Projects R&D Chemaid Sales and Marketing Department: Supply Chain Management Reporting Structure: Senior Project Manager & New Business Execution Reporting to this position: N/A BASIC FUNCTION Supports Senior Project Manager & New Business Execution to ensure the efficient, timely and organized flow of the various Project Development...
-
Assistant Men's Basketball Coach
4 weeks ago
Stony Brook, United States Stony Brook University Full time**Assistant Men's Basketball Coach **Required Qualifications (as evidenced by an attached resume)**: Bachelor’s degree (foreign equivalent or higher). Three (3) years of coaching and/or playing experience at the college level in the sport of basketball. In lieu of college level coaching experience, a combination of four (4) years of coaching experience at...
-
Spanish Faculty
2 days ago
Stony Brook, United States The Stony Brook School Full timeJob DescriptionJob DescriptionJoin the SBS faculty for the 2024-2025 school year!The Stony Brook School is looking for talented, mission-aligned faculty who are interested in working in a boarding school environment! This particular position will bolster our World Language Department and teach Spanish to four or five sections of students. The ideal candidate...