Societal CDMO (formerly Recro) Looking for Quality Systems Specialist – Hybrid at Gainesville, GA  Full Time

Why Join Recro:

Mission and Culture:

Our leadership proactively works to create and foster a culture that exemplifies our core values and mission. We strive to provide a work environment that is diverse, inclusive, challenging, and supportive. We are committed to continuous improvement both as individuals and as an organization and encourage our employees to continue their personal and professional development in a variety of ways.

We strongly believe that every employee plays a crucial role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands on developing, producing or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

Benefits:

We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more!

Your New Role:

We are looking for a Quality Systems Specialist. In this role you will act as the administrator and SME for our electronic quality management system (EQMS) Veeva. You will provide quality oversight of all computerized quality systems to ensure they are maintained in a controlled state. In this role you will also be responsible for managing the “late Items” program, monitoring the due dates for all types of investigations, CAPA, change controls and other controlled documents, ensuring items are closed within the approved timelines.

This position will be a hybrid position, with both onsite and remote work in the Gainesville, GA area.

How You Will Make An Impact:

• Serve as QA subject matter expert (SME) for Veeva and ComplianceWire. Act as committee chair or member for all software steering committees which have an impact on the quality systems (Maximo SlimStat, LIMS, etc.) This includes participating on all teams to modify or upgrade the system.
• Assist in implementation of any new computer quality system and any other quality projects.
• Assist in the execution and/or review of computer system validation documentation.
• Assist in training other departments in the use of the electronic documentation systems. This includes providing one-on-one training as well as group training.
• Review and evaluate reports from the documentation and change control systems and other information as deemed necessary. Investigate trends, prepare reports and notify management of issues needing further review.
• Monitor the due dates of CAPAs, investigations, complaints, audits, periodic equipment / computer software reports, periodic review of documents and change controls or other items as necessary. Prepare weekly status reports and hold periodic meetings with the senior leadership team (SLT) to discuss the status of items and determine action plans for completion. Meet with department heads in a proactive manner to eliminate late items.
• Assist in preparation for Quality Affairs Committee and attend QAC meetings; take minutes and prepare meeting minutes.
• You may participate on the QA Leadership Team.
• Continuously evaluate areas of responsibility and recommend improvements to the processes concentrating on efficiency and quality of the product and/or systems. Ensure Key Performance Indicators measure progress against Quality objectives.
• Support and facilitate change control processes. This includes partnership with change control owners to assist them in the development and execution of change controls or completion of tasks.

Ideal Candidate Will Bring:

• Bachelor’s degree with emphasis in Business, Computer Technology or a scientific field.
• A minimum of 6 years’ experience in Quality Control, Quality Assurance or pharmaceutical manufacturing.
• 5 years’ experience supervising and leading direct reports.
• Experienced in current Good Manufacturing Practices and familiar with simple statistics such as 3 sigma control limits, standard deviation, etc.
• 3 years of direct work experience in developing, executing and evaluating validation of computer systems.
• 3 years of direct work experience with learning management or document control systems, preferably at an administrator level of operation.
• Good project management skills, with experience leading meetings and team projects.
• Strong computer skills and knowledge of word processing and spreadsheet software.
• Competent in pharmaceutical compliance and regulatory policies with knowledge of industry guidelines, trends and practices.

New hires will pass a background check, drug screen, and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.

We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact [email protected].

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If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the “Careers” section.

New hires will pass a background check, drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment. EOE Statement We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. EmpID None Specified

This position is currently accepting applications.