What are the responsibilities and job description for the QA/RA Compliance Specialist position at The Staffing Resource Group Inc?
Job Description
QA / RA Compliance Specialist
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Employment Type : 6 Month Contract - Possible Extend
Environment
This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.
Responsibilities :
Preparation and submission of A / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant / site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
Prepare and submit all federal, state and local permits in timely manner
Interact with Customers and gather information as needed to support registration activities
Provide regulatory impact assessment on all change controls as required
Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader
Assist in regulatory / health authority audits collecting information as requested
Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution
Prepare APRs in accordance with site procedures and timelines.
Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
Assess product complaints and APR trends, provide guidance and collaborate on plans of action to address trends as per site SOPs.
May author other types of quality system documents as directed or assigned by QA management.
Liaise with customers to ensure customer requirements are satisfied.
Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
Author / compile monthly, quarterly and annual summaries and metrics
Other duties as required in support of high performance, such as but not limited to, assisting site management in driving and enforcing cGMPs; mentoring other individuals within the organization in compliance; participating in Internal Assessments; facilitating routine compliance and CAPA Review Board meetings, including follow up actions; facilitating and conducting training.
Requirements :
Bachelor s Degree in Science or related field required (Chemistry, Microbiology or Biology);
A minimum of 3 years related experience in the pharmaceutical manufacturing industry.
Strong background working with Change Controls and management of change control processes.
Keep a pulse on the job market with advanced job matching technology.
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