MQA Specialist

MQA Specialist Quality Assurance (R-MQA)Position Summary:In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. Ensures that manufacturing and packaging operations conform to established company procedures and applicable regulatory requirements by performing daily monitoring of these processes.Performs batch record reviews and batch release according to product acceptance specifications. Evaluates and approves quality investigations and associated corrective and preventative actions (CAPA). The essential duties/competencies for this position include but are not limited to:Performs daily monitoring of manufacturing/packaging operations with a focus on right first timePerforms batch record review and approval based on product acceptance specificationsPlays an active role in solving compliance errors when detected during these processesEnforcement of quality standards and process controlsEvaluates and approves quality investigations and associated CAPAs; may be involved in critical quality investigationsPerforms customer complaint investigationsAssists in training of new colleaguesAssists in internal audits of manufacturing areas/processes; has the ability to perform these audits without assistanceCommunicates with contract customer regarding closure of investigations and batch release status; resolves questions regarding batch record documentationPerforms assigned work in timely and safe manner conforming to regulatory, company, and compendial requirementsMust make effective decisions in a timely manner and be focused on execution until completionRecognizes problems within scope of job and promptly and clearly communicates them to managementRecognizes trends, deviations, problems and promptly reports them to managementFollows directions and demonstrates proper judgment when a deviation occursTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience:Required Bachelor of Science Degree required in Chemistry, Pharmacy, Microbiology, or related technical field and greater than 2 years experience in sterile product operations, pharmaceutical technology, or packaging engineering field Desired Greater than 4 years experience in sterile product operations, pharmaceutical technology, or packaging engineering fieldIf you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:Apply Online To apply for this position, please Apply OnlineAbout MCP Pharmaceuticals, LLC:MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies.MCPs own product portfolio includes leading diagnostic, womens health and anesthesia products. All products have a long track record of gold standard service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.#J-18808-Ljbffr

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