QA RA Compliance Specialist at Aditi Consulting

Job Description:

• 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 our 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
• Assist in other special projects as assigned

Education or Equivalent:

• 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.

Knowledge/Skills Requirements:

• 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.
• Proven ability to multi-task and demonstrate diplomatic skills.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access).
• Working knowledge of cGMPs and/or OSHA regulations required.

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process.  AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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