**Job Title:** Quality Compliance Official **Location:** Swiftwater, PA **Shift:** Tues-Sat or Sun-Thu 1st shift position **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QA Specialist within our QA FFIP will work on Shopfloor in the manufacturing environment​. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** + Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements + Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations + Conducting regular audits of production processes to identify and address potential quality issues + ·Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor + Managing and resolving quality-related issues in a timely and effective manner + Monitoring and analyzing quality performance metrics, implementing corrective actions as needed + Leading root cause analysis investigations for quality incidents and implementing preventive measures + Participating in internal and external audits and regulatory inspections providing support and documentation + Developing and implementing risk management strategies to mitigate potential quality issues + Fostering a culture of quality and continuous improvement across the organization + Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels. + Provide daily floor coverage to support compliance of production (aseptic processing areas (sterile gowning a prerequisite), development, and testing (AQL – eye testing a prerequisite) of all products within functional areas. + Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective actions when necessary, and perform monitoring with respective functional area management to ensure compliance. + Complete risk assessment, minor, and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation. + Manage the CAPA system to ensure that corrective and preventative actions are implemented and completed on time. Provide recommendations to department management regarding CAPA development for process improvements. + Provide support to functional areas regarding the Change Control System by providing assessments, closure, and monitoring. Recommend documentation and supporting data to be included in the Change Control, so proper assessments of cGMP areas can be evaluated, and risk mitigated. + Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures. **Key involvement in Decision Making process** **Key roles (D,A,I)** + Request corrections when GMP rules are not respected (D) + Prioritize quality and compliance objectives (A) + Proactively implement remediation action from findings from internal and external audits related to quality issues (D) + Request quality improvement initiatives and strategies (D) + Identify discrepancies and corrective/preventive actions that need to be taken (D) + Escalate to upper management any failure in GMP execution on shopfloor (I) + Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I) + Advise on how to present a topic and answer specific questions (A) + Advise on risk management strategies and plans (A) + Advise on initiatives to promote a quality-focused culture (A) **About You** **Requirements/Qualifications** **Expected Experience** + Bachelor’s degree in science related field preferred + Minimum of 2 years of experience within the pharmaceutical industry, Biotech, medical device, and lab environment + Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles + Accessing aseptic processing areas, sterile gowning, exceptional eye sight, sampling technique, detail oriented, are requirements to support daily activities of audit readiness and product quality testing (AQL Sampling). **Preferred Qualification:** + Quality Experience **Expected Technical skills** + Ability to analyze complex data and identify trends, issues, and solutions + High level of accuracy and attention to detail in all quality assurance activities + Strong verbal and written communication skills for effective interaction with team members and regulatory bodies + Proficiency in identifying problems and implementing effective corrective actions + Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards **Language** + Local language and English **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SP \#LI-SP \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $57,000.00 - $82,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)