What are the responsibilities and job description for the QA/RA Associate position at Actalent?
Description:
The QA/RA Associate II is responsible for all activities associated with the management of controlled Labeling and compliance with applicable FDA cGMP requirements and other jurisdictions as applicable and also supporting the Quality Assurance and Regulatory Affairs department as needed.
Core Responsibilities include:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Develops strategies and execution of plans for labeling system organization and efficient processes; monitors results and makes adjustments as needed
Establish and manage the Label Control system including, but not limited to:
numbering system
review of master label changes
proof approval, file update, communication to interested parties
coordination with outside printers as needed
Interpret and evaluate labeling regulations as they apply to the company and maintain regulatory intelligence through continuous monitoring of regulatory landscape, identify risks, mitigation, and resolution strategies
Provide coaching, training, mentoring and interaction with QMS staff and other cGMP employees as applicable
Support Document Control as needed
Assist with complaints and investigation
Support final review and sign off on product releases
Supplier Approval/Qualification program support
Assist with Audit and Inspections
Manage the Design Transfer QMS activities
Manage the SDS program
Other QA/RA tasks as required
Skills:
regulatory, regulatory documentation, GMP, cGMP, QA, quality assurance, quality standards, document control, Labeling, Attention to detail, SDS, customer service
Top Skills Details:
regulatory, regulatory documentation, GMP, cGMP, QA, quality assurance, quality standards, document control, Labeling
Additional Skills & Qualifications:
Ideal Candidates have the following traits:
Applied Science or Associate degree in a related field with 3 years of regulated industry experience; or bachelor's degree in a related field with at least 2 years of regulated industry experience.
Experience with SharePoint and Adobe.
cGMP experience in pharmaceutical, medical device, or dietary supplement industry.
Strong interpersonal skills, written, and verbal, proven by effectively presenting information and responding to questions from co-workers, management, contractors, customers, etc.
High attention to detail
Model cGMP-adherent behavior
Able to work in a team-oriented environment and follow SOPs and safety protocols
Self-starter able to take general direction and work independently and with a team
Experience Level:
Entry Level
We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
- Medical, dental & vision
- 401(k)/Roth
- Insurance (Basic/Supplemental Life & AD&D)
- Short and long-term disability
- Health & Dependent Care Spending Accounts (HSA & DCFSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $26 - $29
