Excellent Overseas Opportunity for Quality Assurance/Safety for its overseas company Kaztronix LLC in Rochester, NY. Please send your application with detailed CV, passport particulars and photograph to…
| Position : | Quality Assurance/Safety |
| Location : | Rochester, NY |
| Industries : | Computer/IT Services |
| Education Level : | Bachelor’s Degree |
| Occupations: | General/Other: Quality Assurance/Safety Full Time |
| Status: | Employee |
| Career Level : | Experienced (Non-Manager) |
About the Job :
About Us
Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.
Quality Engineer
Description
Issues and investigates non-conformances using a systematic approach to problem solving, conducts risk analyses and recommends and assures implementation of corrective and preventative actions with the goal to assure quality and minimize risk to consumer. Collaborates with manufacturing and engineering to implement process improvements and reduces product impact due to non-conformances. Partner with manufacturing and other support functions to reduce investigation closure cycle time.
Utilizes industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization forstandardization (ISO).
A Bachelors Degree in a technical field, preferable Science or Engineering. A minimum of 3 – 5 years of relevant work experience within a medical device-manufacturing environment preferred.
Quality Systems and Supplier QA experience is preferred.
| Position : | Sr Associate GRAAS Operations |
| Location : | Thousand Oaks, CA |
| Industries : | Computer/IT Services |
| Job Type : | Full Time Temporary/Contract/Project |
| Job Category : | Accounting/Finance/Insurance |
| Occupations: | Financial Control |
| Career Level : | Experienced (Non-Manager) |
| Education Level : | High School or equivalent |
About Us
Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.
Sr Associate GRAAS Operations
Description
Title (Role) Case Management – Sr Associate (GLOBAL Role)
PV Activity Yes
Specialty Operations
Team Safety Ops
Function Case Management
Level 4
Job Classification Non-Exempt
Group Purpose To support the safety surveillance process for Amgen products by overseeing one or multiple key vendors responsible for the processing of individual case reports
Ensure vendor compliance with approved processes and training requirements
Oversee case quality of all global ICSRs (CT and PM) including analysis and reporting of trends in quality measures
Lead/Single point of accountability for managing one or more key vendor relationships for ICSR processing
Case processing point of contact for case related activities with assigned business partners
Case processing point of contact for audit related activities related to case processing
Accountable for measuring quality against contractual safety agreements
Single accountable FDA point of contact for ICSR reporting
Submission of all individual safety reports to FDA, EMA and Business Partners
Job Summary Case review / QC
Escalation of case level quality issues
Support convention-related training delivery
Perform case deletions
Reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts
Key Activities Perform case review
Support the development and delivery of convention-related training material
Select cases for reporting to FDA, EMA and business partners based on detailed knowledge of legislation & contractual agreements
Ensure compliance of reporting activities with timelines and criteria
Interface with local office staff, CROs and business partners for case processing issues as necessary
Provide E2B submission support (nullification, redistribution)
Address case-related queries from Business Partners
Perform antibody re-testing coordination (non-LAO tasks for repeat testing)
Provide treatment assignments for single case unblinding for regulatory reporting
Knowledge and Skills Understanding of global regulatory requirements for pharmacovigilance
Familiarity with clinical development processes
Case processing experience
Attention to detail
Competence in safety systems and medical coding
| Position : | Administrative Assistant III |
| Location : | Bridgewater, NJ |
| Industries : | Computer/IT Services |
| Job Type : | Full Time Employee |
| Job Category: | Administrative/Clerical |
| Occupations: | Administrative Support |
| Career Level: | Experienced (Non-Manager) |
| Education Level: | Associate Degree |
About the Job :
About Us
Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.
Administrative Assistant III
Duties:
This position performs a variety of business support activities to maintain and support activities for the efficient operation of the Department within the US CRU
Skills:
Detail oriented, highly organized, ability to handle multiple priorities efficiently, excellent interpersonal skills, good communication skills, particularly verbal, reliable, excellent telephone skills, accurate, excellent follow up skills, ability creativity in problem solving situation.
Education:
Preferably 2+ years college education and at least 2 years pharmaceutical experience preferred.
| Position : | Medical Information Specialist |
| Location : | Titusville, NJ |
| Industries : | Computer/IT Services |
| Occupations : | Pharmacy |
| Job Category : | Medical/Health |
| Job Type : | Full Time Employee |
| Career Level : | Experienced (Non-Manager) |
About Us
Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.
Medical Information Specialist
Description
Responds to all on-label and off-label customer inquires for all company marketed and investigational agents received via phone, fax or e-mail.
Utilizes appropriate information and resources to respond to medical information inquiries, documents the inquiry and the response in departmental database
Processes and reconciles adverse events for all company marketed products.
Assists in development of standard and customized responses to customers.
Escalate calls/inquiries to second-line pharmacist when required.
Through regular review of customer contact data, alerts management and Therapeutic Teams of emerging trends or issues.
Present product data to our customers or vendors
Candidate MUST posses a Pharm.D or Rph degree
Healthcare professional with 1-2 years of Drug/Medical Information experience.
Excellent communications, (both verbal and written) skills and computer skills.
Virology experience required. Candidate must demonstrate good understanding of the HIV market place.
| Position : | Validation Engineer |
| Location : | Rochester, NY |
| Industries : | Computer/IT Services |
| Job Type : | Full Time Employee |
| Occupations : | Software Quality Assurance |
| Education Level : | Certification |
| Career Level : | Experienced (Non-Manager) |
| Job Category : | Quality Assurance/Safety |
About Us
Kaztronix is committed to the clients and employees we serve. Our mission is to provide the best and brightest industry talent, solutions, and services available. We have been working with various industries and clients across the United States for nearly 10 years.
Validation Engineer I
Description
Prepares and executes all protocols and reports for validation work. May coordinate all validation activities by constant communication with related departments and personnel; oversees and reviews validation area processes and procedures. Requires a bachelor’s/master’s degree in engineering and 2-5 years of experience in the field or in a related area. Familiar with standard concepts, practices, and procedures within a particular field. Three (3) years GMP experience a plus.
Participates in manufacturing investigations, and both internal and external audits as necessary. Routinely interacts with data management systems such as SAP, Document Management Systems (Matrix One), and Non-Conformance and CAPA tracking (Trackwise).