Quality Control Manager
4 months ago
- The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.
- Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements.
- Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
- Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
- Establish and maintain policy for documentation of all products and perform internal documentation audits.
- Author and review relevant SOPs, validation and other documents.
- Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
- Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.
- Control Master Batch Records, distribution and label verification.
- Perform line clearance activities as required.
- Assign and maintain product lot numbers as applicable.
- Ensure materials management nonconformance disposition and release activity as applicable.
- Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures
- Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
- Provide Quality Assurance related support to various departments.
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
- Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
- Provide support to manufacturing for investigations of deviations, validations, and development of specifications
- Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
- Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.
- Perform employee training on QSR and ISO requirements and company quality systems
- Perform document control activities as assigned.
- Mentor/train/develop and manage Quality Assurance team.
- Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements
- BS Degree in biological sciences or equivalent.
- Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
- Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
- Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
- Sound knowledge of aseptic processing and supporting technologies.
- Analytical and technical troubleshooting skills are a plus.
- Proficient with Microsoft Office Suite.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication skills.
- Strong team-oriented interpersonal skills are essential.
- Travel may be required
- Strong business acumen
- Experience with Visio, Microsoft Project and Excel)
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Strong written and oral communication skills
- Meeting management/facilitation skills/teamwork
- Ability to multi-task is essential
- Flexible and able to adapt to company growth and evolving responsibilities
-
Quality Control Manager
4 months 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 Control Manager
5 days 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 Control Manager
5 days 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 Control Manager, Training and Compliance
3 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Manager, Training and Compliance to join our team. This is a challenging and rewarding role that requires a strong background in quality control, training, and compliance.Key ResponsibilitiesTraining and ComplianceDevelop and maintain a comprehensive training program for the analytical...
-
Quality Control Compliance Investigator
22 hours ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team. As a key member of our quality assurance team, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other quality-related issues.Key...
-
Quality Control Compliance Investigator
3 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Compliance Investigator to join our team. As a key member of our organization, you will be responsible for leading life-cycle investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other events to improve processes and ensure compliance.Key...
-
Senior Quality Control Trainer
4 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewPosition: Senior Quality Control TrainerLocation: Allendale, NJThe Senior Quality Control Trainer is responsible for facilitating and delivering on-the-job training for Quality Control (QC) personnel. This role is essential for the effective onboarding of new employees and the continuous development of existing staff through comprehensive...
-
Quality Control Microbiologist
2 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob SummaryLynkx Staffing LLC is seeking a highly skilled Quality Control Microbiologist to join our team. As a Quality Control Microbiologist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesPerform environmental monitoring activities, including non-viable particulate testing, active air viable, passive...
-
Senior Quality Control Trainer
4 weeks ago
Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewPosition: Senior Quality Control TrainerLocation: Allendale, NJThe Senior Quality Control Trainer is responsible for delivering comprehensive on-the-job training for Quality Control personnel. This role focuses on the effective onboarding of new employees as well as the continuous enhancement of skills among existing staff. The trainer will...
-
Quality Control Analytical Scientist
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical...
-
Quality Control Analytical Associate II
4 months 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....
-
Quality Control Manager
2 days ago
Saddle River, New Jersey, United States Lynkx Staffing LLC Full timeJob Title: Quality Control ManagerLynkx Staffing LLC is seeking a highly skilled Quality Control Manager to join our team. As a Quality Control Manager, you will play a pivotal role in ensuring that our quality control processes are effective and efficient.Key Responsibilities:Lead and manage a team of quality control personnel to ensure compliance with cGMP...
-
Quality Control Microbiology Supervisor
4 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of...
-
Quality Control Microbiology Supervisor
7 days ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQuality Control Microbiology SupervisorAllendale, NJ The Quality Control Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of...
-
Quality Control Analytical Supervisor
4 months 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...
-
Quality Control Analytical Supervisor
7 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...
-
Quality Control Microbiology Engineer III
4 months 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 Assurance Manager
4 months 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 Assurance Manager
5 days 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 Compliance Investigator
5 months ago
Saddle Brook, United States Lynkx Staffing LLC Full timeJob DescriptionJob DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to...