JOB REQUIREMENTS: Summary of role As the Supervisor, Quality Assuranceyou will be accountable for driving results in a fast-paced environmentby effectively managing the Quality Assurance Operations Department andassociated Quality Systems and inventory Systems to ensure compliancewith all regulatory requirements and company procedures. The Supervisor,drives the performance and engagement of the quality assuranceoperations team, specifically those associates that review anddisposition of production records, cleaning records, raw materials,stability and reference standard packets . This leader is accountablefor performing duties in accordance with Standard Operating Procedures(SOP) and driving the performance management, training and development,and continuous improvement of the team. In addition to overseeingquality assurance personnel, this hands-on leader will consult onquality and compliance issues and provide support during regulatoryinspections. This leader will also assist with the developm ent of SOPsor other quality improvements. The position requires superior leadershipbehaviours of the Sterling core values and non-negotiables, as well asexpertise in functional competencies included in this position profile.Your Responsibilities * Ensures GMP Compliance to Regulatoryrequirements and Company Procedures. * Manages Quality Systems toensure timely closure of Observation, Deviations, Investigations,Corrective Actions, etc. * Support and delegates SAP related actionsnecessary for the team * Support cell structure and associated qualityteam support, adjusting as necessary * Supports thorough Root CauseAnalysis for investigations/deviations. * Evaluates corrective andpreventive actions to ensure effectiveness. * Develops and supportsteam Training materials. * Works with the QA Ops team to align andfocus workload and priorities to meet client and site needs. * Performsduties in accordance with Standard Operating Procedures (SOPs). *Provides quality evaluation and review of MPR data. * Maintains qualitydatabases and may perform analysis and trending. Requirements for therole * Strong knowledge of regulations and SOPs applicable to area ofresponsibility and keeps abreast of new regulations and regulatoryguidance in areas of expertise. * Knowledge of cGMP, SOPs, CAPAs,material controls and batch disposition procedure requirements. *Experience with Quality systems required. * Familiarity with DataIntegrity and protecting confidential information required. * Awarenessof change management/ change control procedures preferred. *Bachelor\'s degree in Chemistry, Biology, or related technical field. *2-5 years of related work experience required; 5-8 years preferred. *cGMP experience required. * Prior pharmaceutical or CDMO experiencepreferred. What We Offer We offer a competitive compensation andbenefits package including medical/dental/vision/life insurance, paidtime off, bonus program, 401k match, tuition reimbursement, 24/7employee assistance program, flexible work hours, and the opportunityfor career training and development. Location This position is locatedin Germantown, WI, a vibrant city northwest of Milwaukee in SoutheastWisconsin. A great place to live, work and raise a family, SoutheastWisconsin offers a variety of activities and diverse cultural scene.Diversity and Inclusion Sterling values diversity and we are committedto creating an inclusive environment for all employees. All employmentdecisions are based on business needs, job requirements and individualqualifications, without regard to race, color, religion, sex, pregnancy,age, national origin, physical or mental disability, past or presentmilitary service, marital status, gender identification or expression,medical condi To view the full job description please use the linkbelow.https://www.aplitrak.com/?adid=YmJnZW5lcmljLjE3NjM0Ljg3NzBA 3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ***** APPLICATION INSTRUCTIONS: Apply Online:https://www.aplitrak.com/?adid=YmJnZW5lcmljLjE3NjM0Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ