ACS group has an immediate need for a "Compliance Specialist" with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in Devens, MA. Our client is a leading pharmaceutical company.
Please review the job description below:
Top Skills:
Hiring Manager Comments:
* Experience in a cGMP biopharmaceutical manufacturing environment with demonstrated knowledge of biotechnology processes (e.g.: drug substance/API, drug product, etc.)
* Knowledge of FDA and EU regulatory requirements
* Experience with Change Control and quality systems
Job Description:
Job Description: Quality Product Compliance Project Coordinator
Principle Objective of Position:
The Quality Product Compliance (QPC) Project Coordinator will support the execution of Quality Assurance activities that fall within the Global Quality Key Brands organization. This includes support of marketing and post-marketing changes, global change management implementation planning, as well as supporting other key QPC initiatives and programs. The QPC Project Coordinator will work collaboratively with QPC Management and QPC Project Managers and will also collaborate with the various brand teams and the global Quality organization to reach compliant solutions.
Major Duties and Responsibilities:
Education:
Experience/Knowledge:
Skills/Competencies: Expertise with MS Office, Word, Excel, Sharepoint, MS Teams, Change Control and document management systems
Thanks and regards,
RAHUL GULATI
Team Recruitment
P: (+1)
404-585-5612
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
Recent Awards and Recognitions:
IT and Industry certifications:
Conduct Audits
Interview Skill
Perform Analysis
Perform Regulatory Audits
Conduct Inspection
Please review the job description below:
Top Skills:
- Compliance
- Quality Control
- cGMP
- FDA/EU Regulations
- Pharmaceutical
Hiring Manager Comments:
* Experience in a cGMP biopharmaceutical manufacturing environment with demonstrated knowledge of biotechnology processes (e.g.: drug substance/API, drug product, etc.)
* Knowledge of FDA and EU regulatory requirements
* Experience with Change Control and quality systems
Job Description:
Job Description: Quality Product Compliance Project Coordinator
Principle Objective of Position:
The Quality Product Compliance (QPC) Project Coordinator will support the execution of Quality Assurance activities that fall within the Global Quality Key Brands organization. This includes support of marketing and post-marketing changes, global change management implementation planning, as well as supporting other key QPC initiatives and programs. The QPC Project Coordinator will work collaboratively with QPC Management and QPC Project Managers and will also collaborate with the various brand teams and the global Quality organization to reach compliant solutions.
Major Duties and Responsibilities:
- Advise change record authors on ensuring an integrated approach to change controls and related child actions, driving consistency across sub-teams, brands and sites, including external manufacturing sites.
- Work closely with various brand teams and Global Quality organization to communicate specific timelines to team members to ensure on-time deliverables are completed.
- Assist Quality Product Leads (QPLs) with management of Brand strategies to ensure consistency in product release and market supply.
- Support continuous improvement projects to improve Quality Systems and processes, supporting the team with development and utilization of tools for providing standardized work and communications for group initiatives.
- Perform other related duties and assignments, as required.
Education:
- Bachelor's degree or equivalent experience
- 3-5 years of experience in a Quality role within a cGMP biopharmaceutical manufacturing environment.
Experience/Knowledge:
- Demonstrated understanding of quality processes around post-approval change management.
- Working knowledge of specification/method and change control quality systems.
- Excellent technical writing skills with ability to edit materials to ensure accuracy, clarity, and consistency.
- Ability to work collaboratively with cross-functional teams. Experience with working with/or supporting a matrix environment.
- Strong interpersonal, verbal, and written communication.
- Proven track record of successful management of projects and ability to meet critical timelines.
Skills/Competencies: Expertise with MS Office, Word, Excel, Sharepoint, MS Teams, Change Control and document management systems
Thanks and regards,
RAHUL GULATI
Team Recruitment
P: (+1)
404-585-5612
ABOUT ACS Solutions.
ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.
ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.
ACS solutions has multiple subsidiaries, each focused on the unique area of business:
- Analysts international Corporation (Staff Augmentation Services)
- The Ascent Services Group Inc. (Life Sciences Talent Solutions)
- HireGenics, (Payrolling, IC Compliance, & MSP Services)
- DATA Inc. (Information Technology- staffing)
Recent Awards and Recognitions:
- 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
- Largest Minority IT Staffing Firm in the US. (SIA 2019)
- ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.
IT and Industry certifications:
- Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
- AWS Managed Services Partner
- Google Cloud Partner
- ISO 27001:2013 Certified for Data Security
- ISTQB Gold Partner
- ISMS (ISO 27001:2017)
- SOC2 Type II Compliant
Recommended Skills
Ensure ComplianceConduct Audits
Interview Skill
Perform Analysis
Perform Regulatory Audits
Conduct Inspection