Senior Quality Engineer - Northern NJ - Direct Hire

 Job Title: Senior Quality Engineer

Status: Direct Hire 
Remote: No - Onsite Required in Northern NJ

We are currently seeking a Senior Quality Engineer, Software who will assist and support the organization with computer system and software validation activities. In this role, you will be responsible for performing assessments of computer systems and software processes within a regulated environment; compiling and maintaining the Validation Master Plan and procedures; as well as assisting functional/business owner in creating and executing the require system or software validation plans, documentation and tests.

Qualified candidates should be able to work with various business groups in order to support and provide timely implementation and a successful go-live of validated systems and applications.

Responsibilities

• Perform assessments of current non-device computer systems, applications and software and their related processes.
• Maintain the site’s Validation Master Plan and report in recurring status and review meetings.
• Prepare computer and software validation documents including validation plans, user and functional requirements, configuration specifications, test protocols, and reports.
• Support cross functional organization’s quality and GxP business needs and translate into user and functional requirements.
• Develop, maintain and update work instructions and procedures to define computer system validation standards, templates and processes.

 

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Sciences or a related field (Masters preferred)
• Minimum of 5 years’ Computer System or Software Validation experience in an FDA and/or ISO regulated environment
• Thorough understanding of FDA 21CFR 820 and ISO 13485 regulations
• Thorough understanding of software system verification/validation methodology
• Working knowledge and understanding of Good Automation Manufacturing Practices (GAMP)
• Experiencing in creating test protocols including IQs/OQs/PQs
• Understanding of SDLC and IT/System change management processes
• Project management experience in a regulated environment, preferably medical device, pharmaceutical, or health science as part of an interdisciplinary team
• Excellent problem solving, technical writing, and communication skills
• Must be self-motivated and detailed oriented
• ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) certification a plus

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*If interested, please send me your resume.

LORI MAGEE, CPSR, CPSAE
lmagee@talonpro.com

Recruiting Manager / Account Executive

Talon Professional Services

Regulatory Labeling Associate Role in Lawrenceville, NJ

Position Summary / Objective

The RIM Labeling Contractor is accountable to enter and manage regulatory information in the authoritative system. Specifically this individual will enter global labeling revisions of the Company Core Data Sheets (CCDS) for commercial products. Notifications of these regulatory changes are sent via a RIM workflow to country regulatory managers who assess it against the current local label and plan submissions. The RIM contractor will monitor data quality, accuracy, and ensure country-level data is available in a complete, and timely manner. Create reports/metrics to identify issues and analyze data trends. Function as a strong RIM user, interact with country regulatory associates, address questions and solve problems. Utilizing training on other regulatory processes, this associate will also support ad-hoc RIM requests. Participate in system testing for upgrades by executing scripts and being involved in validation.

Position Responsibilities
• Functions as a process expert for labeling submissions and CCDS updates in the RIM system.
• As a detail-oriented worker, manage daily workload independently understanding the business goals.
• Runs data quality reports to check process compliance on local assessments. Inform country managers of issues. Arrange meetings as needed to advise them on use of
the system and resolve the problems.
• Update data quality trackers and escalate issues when necessary.
• Use Excel to summarize information for inclusion in Power Point presentations provided to management.
• Contributes to and helps identify system and process gaps in labeling. Develop new RIM reports and dashboards.
• Provides support for internal audits, HA inspections and may be asked to contribute to the resolution of corrective preventive action plans.
• Executes operational tasks according to RIM procedures and work instructions.

Degree Requirements - BS/BA in a relevant scientific or technical field preferred

Experience Requirements
• Minimum of 3 – 5 years of relevant experience

Key Competency Requirements
• Demonstrates critical thinking skills and the ability to apply this to daily workload decisions
• Demonstrates awareness of the procedures and decision-making process of government Health Authorities and how it relates to RIM
• Strong understanding of regulatory operations
• Knowledge of computer systems in an R&D environment. Firm knowledge and experience with eCTD, SPL and submission standards. Ability to navigate marketing application submissions structure and content. Basic understanding of electronic records management rules
• Participates in projects and communicates and interacts with internal and external customers
• Practical experience with desktop application software suites
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills.
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Contact
Shashikanth Bandapally
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
Phone: (212) 488-7460
Fax  : (212) 306-0191
Shashikanth.Bandapally@axelon.com

Clinical Project Coordinator - New Brunswick, NJ

 W2 contract only, please call me to discuss the rate***

Manages multiple projects in the clinical packaging and labeling group. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Works cross-functionally with individuals and project teams in various areas. Identifies and reports issues to appropriate levels of management in a timely manner. Manages clinical label text for assigned projects in including proof creation, management, manufacture, and approval. Reviews and approves vendor generated label proofs and other related documents. Generates packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement. Authors and/or reviews procedural documents.

BS degree in Natural Science or related field is required
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Thank you,

Sahnaj Pervin
Phone: (212) 488-7719
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
sahnaj.pervin@axelon.com