Über die Tätigkeit
Reporting to the Director, Quality Assurance, the Annual Product Review (APR) Specialist is responsible for life cycle management program and supports existing quality systems. In addition, the APR Specialist will assist in the scheduling and performance of internal audits throughout the course of the year. The APR Specialist always maintains positive and cooperative communications with all associates, customers, vendors and other third parties.
In this role, you will be responsible for the following:
- Reviews, compiles, organizes, tracks and trends information supporting Annual Product Reviews for Active Pharmaceutical Ingredients (API products), including communication with internal departments and external suppliers as required to assemble the required APR information.
- Prepares APR reports for API products.
- Works under limited supervision and established procedures.
- Ensures that reports are well organized, clear, complete, and meet quality standards.
- Manages and tracks the APR schedule and ensure that report due dates are consistently met.
- Reviews the APR process for improvement to increase efficiency and effectiveness while ensuring compliance with regulatory requirements and expectations.
- Provides support to schedule and perform Internal cGMP Audits.
- Supports regulatory and third-party facility audits.
- Other duties as required by management.
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Basic Qualifications
- High school diploma or GED required; associate or bachelor’s degree in a science-related field preferred.
- Minimum of 5 years of progressive quality assurance/control experience required; pharmaceutical industry experience is a plus. Equivalent combinations of education and experience considered.
- Proficient in reading, analyzing, and interpreting technical documents, regulations, and professional materials.
- Skilled in writing clear and grammatically accurate reports, correspondence, and procedure manuals.
- Strong grasp of probability, statistical concepts, and their practical applications.
- Capable of defining problems, analyzing data, and interpreting complex technical instructions in various formats.
- Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Familiarity with electronic document control and quality management systems preferred.
Core Competencies
- Demonstrates flexibility in responding to change, managing competing demands, and addressing unexpected challenges; utilizes analytical and innovative approaches to identify and resolve issues effectively.
- Upholds ethical standards, inspires trust, and treats others with respect and tact, even under pressure; takes responsibility for actions, maintains confidentiality, and follows through on commitments.
- Excels in teamwork by balancing individual and group responsibilities, fostering a positive environment, and valuing diverse perspectives; communicates effectively in both written and oral formats while actively listening and responding to feedback.
- Prioritizes customer satisfaction by promptly addressing needs, managing difficult situations, and meeting commitments; understands the business implications of decisions and aligns actions with organizational goals and values.
Efficiently plans and prioritizes tasks, ensuring high-quality results and adherence to safety standards; consistently meets productivity expectations, demonstrates reliability, and seeks opportunities for continuous improvement
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Our Benefits
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
- Competitive Salary
- Health, Vision, and Dental Insurance
- Company Paid Life Insurance
- Generous Paid Holidays
- Paid Volunteer Time
- Generous Paid Time Off and Rollover
- Company matching 401K and Retirement Savings Plans
- Employee Assistance Program
- Flexible working arrangements
Fagron North America is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron North America is proud to be an affirmative action and equal opportunity employer.