RE: Multiple Client Requirements :: Sr Manager Quality Assurance - Canton, MA (Locals Only) || Laboratory Systems Analyst (NuGenesis SDMS) - Worcester, MA

[Harry John]

HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement with one of our client’s, please review below job description and let me know your interest

 

Position ID :DYESFK001383

Title: Sr Manager Quality Assurance

Location: Canton, MA

Duration: 3-6 months

 

Locals Only

 

POSITION SUMMARY

Responsible for quality assurance activities/decision making associated with cGMP manufacturing, investigations, change control, complaint investigations and documentation.  Ensures that proper controls are instituted and maintained during the manufacturing, processing, packaging and warehousing of compounded product.

 

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

·         Support implementation of Master Batch Records and associated manufacturing and Quality related systems for the compounding processes.

·         Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.

·         Support problem identification and resolution efforts for quality related issues associated with the compounding operations.

·         Ensure appropriate investigation and closure of incidents, change controls, and complaint investigations; direct implementation of appropriate solutions.

·         Review and approve manufacturing batch records, QC testing, SOPs and other batch related documentation.

·         Assist with internal, corporate, 3rd party and federal/state inspections and audits.

·         Provide reports on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.

·         Represent QA for Product manufacturing and Media Fill execution.

·         Ensure cGMP documentation associated with work activities is complete.

·         Maintain assigned standard operating procedures.

·         Assist in the disposition of incoming material and final product.

·         Performs other related duties as assigned.

 

REQUIREMENTS

·         Bachelors degree in a scientific discipline and at least three years of relevant Quality Assurance experience in a pharmaceutical manufacturing company.

·         Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan) and Trackwise preferred

·         Excellent problem solving skills

·         Ability to work in a fast paced environment

·         Ability to handle a high volume of work and rapidly adapt to changing environment

·         Preferred skills include root cause analysis and six sigma methodology training

 

Title: Laboratory Systems Analyst (NuGenesis SDMS)

Location: Worcester, MA

Duration: 12 Months+

 

Description:
This is a Laboratory Systems Analyst/Technical Specialist Contractor - NOT VALIDATION ENGINEER role!

Candidate must have 5+ years of Life Sciences/GxP experience and 3+ years of Waters application knowledge (i.e. NuGenesis SDMS, Empower, Vision Publisher ELN) from an Information Technology perspective. Waters application knowledge should include system administration experience and implementation of new software releases. Provide system and validation support for IT projects and ongoing activities supporting existing applications. The position is responsible for ensuring that software quality assurance is applied to IT Projects while meeting project objectives and deliverables. Candidate needs to be able to develops test/validation plans and conducts the necessary tests to confirm functional and design requirements. The responsibilities also include writing test protocols, supporting testing activities, and documenting problem resolution.

 

·         Experienced system integrator – deploying and validating manufacturing systems in GMP Environment.

·         Responsible for providing general lab instrument software and PC support encompassing instruments and software such as Agilent HPLC, OpenLAB ECM, ChemStation, GE AKTA, UNICORN, etc.

·         IT support experience with good understanding of operating systems, networking components, data integrity, data security and database structures. Experience with PI Historian/OPC a plus.

·         Experience in migrating to new software versions of NuGenesis SDMS v8, Empower 3 and Vision Publisher (ELN).

·         Analysis and Problem Solving - Applies analytical thinking skills to diagnose, and make recommendations on system issues.

·         Teamwork - Works effectively with team/group to accomplish organizational goals

Education:
Bachelor’s degree preferred in a relevant discipline; 5+ years of related experience.

Accountability / Scope:
The individual works under general management direction. Determines business objectives of assignments and contributes to the design of systems, programs and processes; completes project tasks within time and budget constraints.

 

Thanks & RegardS

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 719-7902 / (847) 874-7274
© 224-635-0898
Email: ha...@dynamic-enterprise.net
URL: http// www.dynamic-enterprise.net

 

[Harry John]

Position ID: DYSAL0083692

Title: Digital & e-commerce Application Support Manager, (AEM & DevOps)

Location: Waukegan, IL

Duration: 7 Months+

 

Locals Only

 

USC & GC Preferred , consultant must be on our W2

 

Description of Role

Pharmaceutical Client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

We are looking for an Application Support Manager for our Global Digital & eCommerce Operations team reporting to the Enterprise Digital Architect with expert-level knowledge in incident management and resolution, customer communication, diagnostics, monitoring, alerting and measuring availability in a cloud computing environment. The ideal candidate has extensive experience monitoring and proactively reporting on support tickets as well as ensuring the stability and reliability of our Global Digital Marketing & eCommerce sites across various divisions of Pharmaceutical Client generating over $1B in revenue annually, increasing customer satisfaction, and protecting brand reputation.

 

CORE JOB RESPONSIBILITIES

·         Manage a global team of application and platform support engineers responsible for the 24x7 operations of our Global eCommerce & Digital Marketing sites

·         Develop templates and prepare metrics reports on application performance and availability, ticket trends, recurring incidents, and how these measurements reflect against target SLAs/SLOs

·         Lead incident resolution of major operational Incidents to restore service as soon as possible minimizing business disruption. Ensures responsiveness and resolution meets or exceeds prescribed SLA’s

·         Lead and participate in the transition plan development for IT projects from delivery to operational readiness via support model definition and knowledge transition activities

·         Lead incident calls and coordinate activities across Support, Engineering and Operations teams ensuring proper engagement through resolution including production of RCA

·         Work closely with product owners to break down complex customer support problems into organized epics/feature/story backlog and foster strong relationships with business stakeholders, technical management, architects and engineering resources

·         Plan for operational readiness and effectively communicate product launches, features and changes to customer support agents and other internal teams

·         Analyze, plan and execute simulations across digital solutions to identify & remediate performance problems, prevent production outages, and guarantee predictable performance

·         Instrument the complete architecture to provide user and system performance insights into the root cause of all application bottlenecks and enable real time visibility to reduce risk exposure

·         Define the strategy for enabling performance diagnostics and monitoring through the use of Infrastructure, Application Performance Management (APM), other monitoring tools, and diagnostic techniques

·         Measure the stability and reliability of specific processes and end-to-end performance. Developing dashboards and reports to provide ongoing visibility into the performance of our sites to all levels of the organization

·         Partner with application delivery teams to ensure proper release processes are defined and followed prior to deployments, deployment of changes using the existing tool chain

·         Participating in re-architecture, redesign, and refactoring decisions to satisfy performance requirements

·         Leading with a prevention mindset and ability to coach junior engineers with a continuous improvement mindset

·         Help drive plans to ensure stable steady-state production operations

​

Education/ Experience  

·         Bachelor’s Degree in Computer Science, Computer Engineering or related field is required

·         10+ years of experience in IT Operations or Support including supervisory experience

·         Extensive experience in Reporting, Trend Analysis, Problem and Change Management

·         Ability to translate incident and availability metrics into consumable materials to be shared with executive leadership

·         Thorough understanding of performance impacts and application issues that affect availability and how to proactively

·         AWS operations, infrastructure and APM monitoring in New Relic APM, Java, AEM (preffered)

 

 

PREFERRED REQUIREMENTS:

·         Experience in Health Care industry is preferred

·         Considerable experience in identifying, developing and executing support initiatives to improve efficiency and overall customer satisfaction

·         Experience operating the Magento eCommerce platform and or Adobe Experience Manager (AEM) preferred

·         Experience with containerization technology such as Docker and Kubernetes

·         Proven experience in overseeing global 24x7 application and infrastructure operations teams

·         Experience or strong knowledge with cyber security and compliance strategy (PCI DSS, PHI, GDPR etc.)

·         Experience leveraging CI/CD for deploying application components by leveraging DevOps tool chain – JIRA, Confluence, JFrog, Artifactory, Jenkins, SonarQube, Veracode, Selenium, etc.

·         Experience leading geographically distributed teams

·         Experience working with external suppliers and strategic sourcing partners with globally dispersed teams

·         Excellent oral and written communication, presenting, meeting facilitation, negotiation, decision making, and problem-solving skills

 

Thanks & RegardS

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008

(847) 719-7902 / (847) 874-7274
© 224-635-0898
Email: ha...@dynamic-enterprise.net
URL: http// www.dynamic-enterprise.net