Sr. Quality Specialist I, Quality Systems (Onsite - Wilson, NC)
Rhodes Pharmaceuticals L.P. has developed and distributed quality pharmaceutical products nationwide since 2008. With our R&D capabilities, industry partnerships, broad customer base, and strong relationships with suppliers, we offer reliable supply of high-quality products at competitive prices.
At Rhodes Pharmaceuticals L.P., you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team!
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy, as well as our work. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect grounds in our Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
We respect diversity and accordingly are an equal opportunity and an affirmative action employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.
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The Sr. Quality Assurance (QA) Specialist I is a position that supports several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal SOP’s. Primary responsibilities include coordinating documentation in support of global submissions, routine SOP revisions, Annual Product Reviews, Batch Record Issuance, and EDMS (MyQUMAS) Administration.
- Ensures that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e. GxP, etc.).
- Administration of company Electronic Document Management System. This includes but is not limited to supporting maintenance of the system’s validated state, as well as configuring the system to meet new business and user needs.
- Compiles global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
- Supports the review and approval of data and documentation for the preparation of Annual Product Review Reports (APRs).
- Provides support with product and process investigations and data analysis, as requested by Quality management.
- Utilizes knowledge of regulatory requirements to identify, describe and communicate issues and participates in problem resolution and corrections.
- Initiates, tracks, and provides support for problem resolution as required through the Quality Management System and notifies necessary departments of issues.
- Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
- Authors, revises and approves job related controlled documents.
- Maintains all accurate regulatory documentation.
- Provides guidance to personnel from a wide range of departments relative to documentation issuance, handling and archival, annual product reviews, MyQUMAS.
- Evaluates accuracy, completeness and adequacy of data/reports from internal and external sources.
- Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance of the business.
- Organizes and facilitates activities for assigned projects as assigned.
- Communicates and participates in identified improvements as well as mitigation of potential gaps.
- Supports regulatory inspections, as requested.
- Performs other related assignments and duties as required and assigned.
Education and Experience Requirements
BS required and 6 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 4 years minimum relevant experience.
Necessary Knowledge, Skills, and Abilities
- A thorough understanding and working knowledge of Quality Systems and tools.
- Demonstrated sound understanding and well-developed working knowledge and ability in primary discipline.
- Knowledge of GxP and FDA regulations acquired through experience, training, or education; and awareness of impact on cross functional areas.
- The ability to effectively compile/report data and the ability to assist with administration of a Quality System is required.
Supervisory Responsibilities (if Applicable)
The incumbent reports to the Sr. Manager, Quality, Documentation Systems. The position has no direct supervisory experience over subordinates. The incumbent must:
- Possess the ability to independently prioritize workload.
- With minimal guidance and supervision, conducts routine and non-routine activities in the primary discipline with minimal guidance and supervision.
- With minimal guidance and supervision, plans, performs, and reports to management regarding QA and compliance activities.
- May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
Physical and Environmental
- Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
- Ability to work standard schedule of 10 hours a day, Monday-Thursday and overtime as needed.
The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.
- Job Family Quality
- Pay Type Salary
- Wilson, NC, USA