Quality Assurance Manager
Los Angeles, CA
6+ years of experience in a quality assurance or quality control role within a cGMP environment; or equivalent combination of experience, training and/or education preferably in OTC or Pharmaceuticals.
Supervisory experience is required.
In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations.
Solid operating skills including timely decisions, managing and measuring work along with good overall time and project management.
Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master regulatory/compliance software.
Experience in electronic enterprise quality management and documentation systems are a plus.
Demonstrate strong technical ability and skills in assigned work area to include product, process and/or testing knowledge.
Ability to understand and set priorities and work load and to establish collaborative relationship with peers.
Strong interpersonal skills to positively and professionally interact with colleagues and work in a team oriented environment.
The ability to prepare and present reports to management pertaining to non-conformances.
Ability to multi task and handle a heavy volume of work.
Ability to work independently and under pressure.
Strong verbal and written communication skills.
Ability to work with a high degree of accuracy and detail.
The Manager, Quality Assurance is responsible for supporting the process of incoming material inspections, overseeing on-the-floor QA activities which include line releases and inspections. The QA manager plays a crucial support role in investigations, CAPAs and change controls. The QA manager will ensure that the operations are at a state of inspection readiness and that applicable SOPs are adhered to and cGMP is practiced. The main objectives are to ensure inspection ready status, manage and/or complete day to day Quality functions and to assist, train, and develop staff to identify and address issues related to FDA compliance, and be able to adjust quickly to changes as needed.
Responsible for assuring the quality of products manufactured at the facility.
Manage the evaluation and disposition of outsourced and in-house generated labels, cartons and inserts.
Manage the inspection and disposition of incoming components.
Support product batch record reviews and evaluation process as well as assist with required follow ups and investigations.
Hands on management and support of floor QA activities including but not limited to line release, batch clearance, quality hold and destruction processes.
Work closely with the Quality Control department to coordinate the disposition of raw materials and finished products in a timely manner.
Support the approval of Work Request Orders in Master Control.
Manages quality operations and compliance as well as inspection preparedness.
Interpret and implement scalable solutions which include quality policies.
Conduct investigations, and root cause analysis and identify root cause(s).
Recommends and implements corrective actions to prevent recurrence in collaboration with Quality Systems.
Initiate and implement CAPAs to address findings, issues and non-compliances in the facilities.
Practice Change Management utilizing risk based strategy.
Perform trend analysis to monitor process performance and report monthly production floor discrepancies and self-inspection to department head/manager.
Implement metrics to track the performance of operations and quality systems and report monthly quality KPIs.
Lead the Quality teams in the design of control strategies for new processes.
Assure that Quality and Manufacturing comply with cGMP, and other regulatory and industry standards.
Authors and revises SOP, protocols and work instructions as required, and performs risk assessments.
Continually evaluates quality systems supporting cGMP manufacturing operations for potential improvements.
Participate during FDA inspections and internal audits.
Manage and develop staff, and set priorities.
Perform all other related job duties as assigned and/or requested by company management.
Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations.
Role: FullStack Engineer
Location : Bloomington, MN
Duration : long Term
Work closely with product owners and teams to lead feature implementation and/or source third party solutions when appropriate. Contribute to standards and best practices around development processes, coding, and peer reviews. Optimize existing systems to improve performance and scalability through service/application tuning and code refactoring. Fully and properly test code to ensure the highest levels of reliability and maintainability. Research and recommend software solutions and tools that help fix inefficiencies in the development process, team collaboration, etc. Help lead and drive development operations initiatives. Provide assistance to CM, QA and support personnel as needed to troubleshoot lower environment as well as production issues. Resolves customer complaints and responds to suggestions for improvements and enhancements.
Minimum Required Skills
Experience working in agile environment highly preferred Experience in creating design documents, performing code reviews and test driven development Desire to expand knowledge in many development languages, applications, and tools Proven ability to quickly learn new processes and tools, business domains and technical applications Ability to think technically and analytically Ability to understand philosophy of architecture. Must assimilate information, distill knowledge, apply experience and provide solution alternatives and recommendations Must have strong time management skills - including ability to work well under pressure, plan, set priorities, adapt to change, and meet established timelines Must develop effective relationships with internal and external contacts and work well within a team Must be a self-starter and detail-oriented Must have a “positive” and energetic demeanor Effective written and verbal communication skills Creative problem-solving skills
Experience with some or all of the following tools (Required): Java SE and EE (3 - 5 years)
Spring (1-2 years) Web Services (SOAP/REST) (1-2 years) SQL (3-5 years) Requirements & analysis experience OOAD design agile development Design patterns
Additional Job Details
Experience with some or all of the following tools (Preferred):
JBOSS or Tomcat
SQL Server (Transact-SQL)
Minimum Education Requirement
Bachelor's degree in Computer Science, MIS, or equivalent technology discipline 3+ years minimum Java development required 1+ years programmatic interaction with relational database systems Current
Technology stack: Java, JPA, Hibernate, Web Services
(REST/SOAP), AngularJS, JQuery Experience in OOAD, agile processes, design patterns,
SQL and UML
Location: Santa Clara CA
Duration:6 + Months
Client: Confidential ( Will keep updated in further development)
Rate: Depends on Experience (Open)
We are looking for Bigdata Engineer in NYC, NY, please read the below requirement and send me your resume if you feel comfortable.
Position : Big Data Engineer
Location: Location: NYC, NY
Duration : 6 Months +
Must be strong in Java and Kafka
Overview of the profile we're looking for:
Established Manufacturing Company with facilities in multiple locations. They are looking for a hands-on Infrastructure Engineer with a background in desktop, systems, and network administration capable of handling service tickets and/or project tasks in a fast-paced environment. Daily administration of LAN/WAN, Networking, Systems Administration, Telephony and Firewall/Security Issues. The Infrastructure Engineer must be capable of performing well in a team environment and possess a multitude of following competencies, knowledge, and skills.
Knowledge and Skills
Bachelor’s Degree, Technical school, or related certifications
Here is the Job Description, If you are interested Please reply back with your updated resume.
Position : ENS (Edge Network Services) Data Center.
Fort Worth, TX
Mode : Full time only.
Job Description -
ENS Data Center
Job Description of ENS (Edge Network Services) Data Center:
While working in ENS -DC, our duty is to provide break-fix services across the production data center network. Maintaining the fleet requires to monitor, react, respond, troubleshoot, and fix issues across network devices. This includes but is not limited to Cisco, Juniper, Arista switches and routers. The ENS DC Team identifies what pieces and parts have failed, and then fix or replace those parts to ensure the network devices run optimally and redundantly. This includes both hardware and link troubleshooting.
Install large-scale production and corporate network infrastructure including routers, switches, console servers and optical transport equipment.
Role: IBM Portal Server developer with Java
Location: Phoenix, AZ
Hope you are doing great!!!
Let me know if you are interested in this below opportunity.
Title: Java Fullstack Developer
Location: Fairfield, OH
Duration: Long Term
I hope you doing well, please share your available consultants profiles,
We have an immediate need for the following opportunity with our client. If you are interested and available in job market kindly go through the following job details.
Title: Oracle GRC consultant
Location: Milpitas, CA or San Jose, CA
Duration: minimum 9 Months and can be extended further as well
CISA (Certified Information Systems Audit) Qualified
Bachelor’s degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
At least 10+ years of experience with IT with experience in implementing Oracle GRC or Equivalent tool set
Extensive experience with SOD Analysis/Resolution/Mitigation, Sensitive Access identification/mitigation, Identification of Finance controls in a cross functional ERP implementation in Manufacturing environment
Ability to connect with Security and Controls team with in IT, Internal Audit and Finance control group with in customer organization
Ability to assess, plan and execute Security and Compliance requirements for ERP implementation
Consulting experience around analysis/resolution/mitigation of Segregation of Duties (SODs), Identification and mitigation of Sensitive Access.
Designing SOD risk libraries by conducting workshops with business process owners and optimization of the same on a long term basis
Resolving client risk management issues leveraging continuous control monitoring, SOD preventive checks, access provisioning & other functionality of GRC suites and defining of SOP’s.
Defining the Standard Operating Processes (SOP’s) around GRC for effective compliance on an ongoing basis
Excellent analytical skills which have been used to develop multiple templates for optimizing risk libraries, quick win SOD remediation templates, responsibility mining activities
Prior Preventive Enforcement Agent (PEA) functionality implementation experience
Ability to work in cross-functional team involving technical and functional consultants and the end user.
In-depth knowledge of Oracle GRC tools (Optional): Access Controls Governor (ACG), Configuration Controls Governor (CCG), Transaction Controls Governor (TCG) and Preventive Controls Governor (PCG) with end to end implementation experience of all the four modules
Past experience with understanding and implementing SDLC audit requirements and working with customer internal audit team to get audit clearance
Excellent understanding of the Oracle EBS Application controls that are incorporated in various business processes.
Thanks & Regards,
Lead Recruiter | IBP Technologies Inc.