Share Email Opening Title Sr. Manufacturing Associate  Category Manufacturing   Description Why Join Societal CDMO?   Mission and Culture: Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands-on developing, manufacturing, 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. We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways. 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 At Societal: We are looking for a Sr. Manufacturing Associate to join our Manufacturing group. In this role you will manufacture a variety of pharmaceutical products and perform complex tasks in a cGMP environment. As a Sr. Associate you will mentor, coach and train junior team members and lead special projects in the manufacturing area. How You Will Make an Impact: Setup, operate, clean and perform basic maintenance of equipment and rooms used in the manufacturing processes to eliminate quality issues. In partnership with a validation Engineer, you will develop validation protocols and lead validation activities for new equipment and processes. You will Provide guidance to junior Associates on completion of validation activities. Troubleshoot and repair complex issues with manufacturing equipment. Engage with Facilities and Vendors for guidance and support. Author and revise SOP’s specifications, batch records and other documentation based on lessons learned during manufacturing or validation process. Perform material management activities – weigh, stage, and load materials; package final product; account for material used, lost in production processes, and/or returned to inventory. Perform regular audits to proactively identify safety and environmental hazards and evaluate possible corrective actions to mitigate issues. Support the identification and installation of new equipment, identifying key requirements and operating parameters, suggesting vendors, participating in equipment qualification activities on a more independent basis. Partners with Facilities or facility related requirements to support new equipment. Identify and investigate complex deviation and out-of-specification (OOS) or out-of-tolerance (OOT) results, to determine root cause and corrective and preventative actions. May partner with cross-functional teams to develop action plans for more complex CAPA activities. Identify and lead continuous improvement efforts for the department.     Position Requirements Ideal Candidate Will Bring: High school diploma or General Education Degree (GED) is required. A Bachelor’s Degree in a technical area is highly preferred. 7 years of relevant work experience in a pharmaceutical or similarly regulated environment is required. Advanced knowledge of cGMP regulations and equipment typical in a pharmaceutical manufacturing operation is required. Experience with troubleshooting and repairing complex automated and semiautomated manufacturing equipment. Proven ability to establish and maintain good rapport with work colleagues, to mentor and train others, and to facilitate conflict resolution. Ability to work independently or with a team in an effective manner. Exemplify teamwork and ability to build and maintain excellent working relationships. Effective written and oral communication skills. Ability to prioritize work of self and others based on operational needs and react quickly to changes in priorities and timelines. Experience with continuous improvement tools such as; 6S Lean, brainstorming, value mapping, 5 Why's, etc. is highly preferred. Ability to add, subtract, multiply and divide in all units of measurement, using whole numbers, common fractions and decimals. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.     About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. 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 not accepting applications. 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