28 QA lead technical operations Jobs in Devens, MA
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QA lead technical operations
$114k-138k (estimate)
Contractor | Business Services
1 Month Ago
Net2Source is Hiring a QA lead technical operations Near Devens, MA
Net 2 Source 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.
Title: Quality - QA lead technical operations Duration: 10 months (Contract) Location: Devens, MA 01434
Pay: $ 60 - 65/hr on W2 Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
Job Description/ Responsibilities: • Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• Able to interpret complicated data and make sound decisions, Independently
Sometimes will interact with departments listed below: Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications: • Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience
• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving
• Knowledge of Data integrity principles
• Proven attention to details
• Comfortable working in an FDA regulated environment.
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 in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with 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:
Title: Quality - QA lead technical operations Duration: 10 months (Contract) Location: Devens, MA 01434
Pay: $ 60 - 65/hr on W2 Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
Job Description/ Responsibilities: • Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• Able to interpret complicated data and make sound decisions, Independently
Sometimes will interact with departments listed below: Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant
Education, Experience, and Qualifications: • Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience
• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving
• Knowledge of Data integrity principles
• Proven attention to details
• Comfortable working in an FDA regulated environment.
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 in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with 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 the 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% of 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)
Job Summary
JOB TYPE
Contractor
INDUSTRY
Business Services
SALARY
$114k-138k (estimate)
POST DATE
05/28/2024
EXPIRATION DATE
09/16/2024
WEBSITE
net2source.com
HEADQUARTERS
SOMERSET, NJ
SIZE
200 - 500
FOUNDED
2007
TYPE
Private
CEO
ASHISH GARG
REVENUE
$50M - $200M
INDUSTRY
Business Services
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About Net2Source
Net2Source provides application development, workforce management and project consulting services for healthcare and finance industries.
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