**Job Purpose** + The Specialist Quality Assurance is responsible for providing support to the Quality Assurance department. + This role will work with cross-functional teams to maintain internal Quality Systems. + Key Roles and Responsibilities + Assist in the execution of Quality Systems to support GLP, GMP and GCP, including both internal and external work + Support internal GxP activities + Administer, follow-up, write, review and approve Quality System documentation (deviations, investigations, CAPA) + Review and help approve all GxP documentation including master batch records, labels, protocols, forms, stability data and reports + Assist with tracking and trending of Quality System metrics (deviations, investigations, CAPA, etc.) + Write, review and approve SOPs and Forms + Help to maintain equipment related to GMP testing and manufacturing + Help maintain Qualitys Supplier Qualification Program + Help maintain other GxP programs as needed + Assist with internal and external audits as needed **Qualification, Skill and Competencies Requirements** + BA/BS in Life Sciences + Minimum of 2 years GxP experience + Strong knowledge of MS Word and Excel + Excellent written and verbal communication skills + Must be able to work both independently and in a team situation The presently-anticipated base compensation pay range for this position is $95,500 to $106,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.