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Hiring _ QA/RA Compliance Specialist _ St. Petersburg FL
$61k-76k (estimate)
Contractor | Business Services
3 Weeks Ago
intellectt is Hiring a Hiring _ QA/RA Compliance Specialist _ St. Petersburg FL Near Petersburg, FL
Job Title: QA/RA Compliance Specialist
Location: 2725 Scherer Drive North, St. Petersburg, FL 33716 Duration: 06 MONTHS.Timings: MON - FRI 8AM - 5PM OR 9AM - 6PMDescriptionIII. Specific Activities, and Responsibilities:
Direct: 1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Location: 2725 Scherer Drive North, St. Petersburg, FL 33716 Duration: 06 MONTHS.Timings: MON - FRI 8AM - 5PM OR 9AM - 6PMDescriptionIII. Specific Activities, and Responsibilities:
- Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
- Provide initial regulatory impact assessment on all change controls as required.
- Liaise with customers to ensure customer requirements are satisfied.
- 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
- 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.
- May author other types of quality system documents as directed or assigned by QA management.
- Other duties as required in support of Catalent Pharma Solutions 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.
- Assist in complying with any other company and /or departmental objectives as directed by the Group Leader
- 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.
- Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
- Prior regulatory affairs, quality control or quality assurance experience is a must.
- Working knowledge of US application regulations and cGMPs, and FDA Guidance for both.
- Excellent organization skills and extreme attention to detail are a must.
- Excellent oral and written communication skills.
- Motivated, self-started, team player.
- Able to reflect a strong quality work ethic.
Direct: 1 (732) 769-3893
Desk Number: 732-412-6999 Ext: 274
https://www.intellectt.com/
517 Route 1 South, Suite 1115 Iselin, NJ 08830
Job Summary
JOB TYPE
Contractor
INDUSTRY
Business Services
SALARY
$61k-76k (estimate)
POST DATE
06/04/2024
EXPIRATION DATE
08/18/2024
WEBSITE
intellectt.com
HEADQUARTERS
ISELIN, NJ
SIZE
200 - 500
FOUNDED
2018
CEO
KIRAN MADALA
REVENUE
$5M - $10M
INDUSTRY
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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