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 in 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. We encourage our employees to continue their personal and professional development in various ways.Your New Role At Societal:In this role, you will partner with the various departments to find corrective actions and prevent future reoccurrences and participate in meetings with the various groups to develop long term corrective actions and follow-up or to resolve issues.
- Review and release components associated with their product lines.
- Review and approve deviations and investigations for acceptability.
- Participate in data gathering for reports, investigations. Input information into databases. Trend and evaluate information for small projects.
- Perform non-conformance investigations and write the subsequent reports
- Write and/or revise procedures, specifications, and change controls as required assuring that related CAPAs are completed on time.
- Perform CAPA effectiveness checks
- Performs other activities related to Quality Assurance as directed by management.
- Assist in internal and external audits in conjunction with the QA Auditor
- Prepare reports as requested by management.
Ideal Candidate Will Bring:
- Generally, zero to one (0-1) years of experience in a relevant field, with a bachelor's degree in a scientific field.
- Knowledge in Good Manufacturing Practices
- Knowledge of pharmaceutical industry guidelines, and practices.
- Strong analytical skills, with an ability to use logic and simple statistical concepts to identify potential problems and trends.
- Strong written skills, procedure, and protocol generation.
- This position interacts with a wide variety of topics and personnel and must be able to gather information from multiple sources.
- Proficient in Microsoft Office
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)