GMP Quality Assurance Specialist | Training & SOPs

The Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing release documents and data, conducting basic floor audits, consulting on quality and compliance issues, and performing quality and compliance training as needed. The Quality Specialist assists with the development of SOPs or other quality documents as needed. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile. Your responsibilities Performs quality review and approval of batch specific documents, cleaning documents, reference standard and all types of data. Performs quality release of intermediates, active pharmaceutical ingredients (APIs), and raw materials. Drafts and reviews Certificates of Analysis (CoA) and Certificates of Conformance (CoC). Performs area clearance and release of equipment and facilities for GMP use as required. Assists with development/writing of SOPs or other quality documents and/or reports as needed. Provide training in quality and compliance topics in areas of expertise. Maintains accurate files and records. Requirements for the role Bachelor’s degree in chemistry, Biology, or related field with 3+ years GMP related experience, or Master’s degree in related field with 1+ years related experience, or equivalent educational and work experience. What we offer We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development. Location This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family. Diversity and Inclusion Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law. #J-18808-Ljbffr Sterling Pharma Solutions