Address
Form of workNet2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Positio title: QA Shop Floor Specialist
Duration: 06 months
Location: Summit, NJ 07901
Pay Rate: $ 35.00/hr on W2
100% onsite
1st shift- Normal business hours
Job Description:
Quality Systems support within Quality Operations, External Manufacturing. Ensure that Client Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives. In addition ensure effective management of change controls, product quality complaints and CAPA.
Major duties and responsibilities:
Audit and disposition executed batch records pertaining to the preparation, formulation, granulation, final dosage form and packaging process of products manufactured at Third Party Manufacturing (TPM) sites.
When required compiles required disposition documentation (i.e. Contract Audits, FDA Import Documentation) needed for release of specific products. Maintains files for all lots of materials released by Quality Operations, Ext. Mfg.
Ensure product compliance with current specifications, procedures, validation requirements.
Alert management on trends noted during the evaluation of manufacturing documentation and verify with the TPM actions taken in order to restate control.
Input all necessary information into applicable enterprise-wide systems (Trackwise & SAP) related to third party manufactured products, e.g., lot disposition, product quality complaints, change controls, CAPA.
Document errors found during the auditing process and assure adequate corrections are documented.
Categorizes and reports documentation errors and deviations in order to notify management of trends and focus on the required corrective measures.
Provides input to management on the need of revision of manufacturing instructions based on trends, documentation errors or supplemented information.
Participate in Regulatory and Compliance audits FDA, DEA, EU, etc as needed.
Exercise leadership, team skills, self confidence, and effective decision making throughout projects.
Writes, reviews and implements procedures to assure update with current practices, audits or cGMP. Generates Certificate of Analysis, Certification of Conformance, Release Notifications and other release documentation as required by our customers or regional partners.
Participates in investigations related to the areas of supervision in order to monitor, measure and optimize or achieve the QA Department and Company goals.
Maintain extensive communication with TPMs and other Client groups such as Manufacturing Technology, Supply Chain, and Project Management Serves on Fact Finding or other project teams as assigned
Other duties as assigned by manager
Education:
B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
Experience / Knowledge Desired:
A minimum of 3 years of experience in pharmaceutical Quality Control and/or Quality Assurance, with direct experience in drug product release and the use of Quality related enterprise-wide systems, i.e., Trackwise, LIMS (QCMain/Sample Manger) and SAP.
Experience in solid dosage forms and parenteral manufacturing desired.
Knowledge of compendial requirements, testing standards and specifications, regulatory filing documentation and cGMP, FDA regulations and the ability to interpret and apply them.
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.
Good verbal and written communication skills essential.
Excellent interpersonal skills at every level.
Capable to manage multiple priorities.
Additional Job Requirements:
Position Handles Hazardous Materials
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
Positio title: QA Shop Floor Specialist
Duration: 06 months
Location: Summit, NJ 07901
Pay Rate: $ 35.00/hr on W2
100% onsite
1st shift- Normal business hours
Job Description:
Quality Systems support within Quality Operations, External Manufacturing. Ensure that Client Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives. In addition ensure effective management of change controls, product quality complaints and CAPA.
Major duties and responsibilities:
Audit and disposition executed batch records pertaining to the preparation, formulation, granulation, final dosage form and packaging process of products manufactured at Third Party Manufacturing (TPM) sites.
When required compiles required disposition documentation (i.e. Contract Audits, FDA Import Documentation) needed for release of specific products. Maintains files for all lots of materials released by Quality Operations, Ext. Mfg.
Ensure product compliance with current specifications, procedures, validation requirements.
Alert management on trends noted during the evaluation of manufacturing documentation and verify with the TPM actions taken in order to restate control.
Input all necessary information into applicable enterprise-wide systems (Trackwise & SAP) related to third party manufactured products, e.g., lot disposition, product quality complaints, change controls, CAPA.
Document errors found during the auditing process and assure adequate corrections are documented.
Categorizes and reports documentation errors and deviations in order to notify management of trends and focus on the required corrective measures.
Provides input to management on the need of revision of manufacturing instructions based on trends, documentation errors or supplemented information.
Participate in Regulatory and Compliance audits FDA, DEA, EU, etc as needed.
Exercise leadership, team skills, self confidence, and effective decision making throughout projects.
Writes, reviews and implements procedures to assure update with current practices, audits or cGMP. Generates Certificate of Analysis, Certification of Conformance, Release Notifications and other release documentation as required by our customers or regional partners.
Participates in investigations related to the areas of supervision in order to monitor, measure and optimize or achieve the QA Department and Company goals.
Maintain extensive communication with TPMs and other Client groups such as Manufacturing Technology, Supply Chain, and Project Management Serves on Fact Finding or other project teams as assigned
Other duties as assigned by manager
Education:
B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
Experience / Knowledge Desired:
A minimum of 3 years of experience in pharmaceutical Quality Control and/or Quality Assurance, with direct experience in drug product release and the use of Quality related enterprise-wide systems, i.e., Trackwise, LIMS (QCMain/Sample Manger) and SAP.
Experience in solid dosage forms and parenteral manufacturing desired.
Knowledge of compendial requirements, testing standards and specifications, regulatory filing documentation and cGMP, FDA regulations and the ability to interpret and apply them.
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.
Good verbal and written communication skills essential.
Excellent interpersonal skills at every level.
Capable to manage multiple priorities.
Additional Job Requirements:
Position Handles Hazardous Materials
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
