Career Opportunities
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Title: Quality Auditor Department: QCI Location: Santee, CA Schedule: Mon-Fri, 1st Shift Description: The QA Auditor position is responsible for planning, organizing, conducting and managing Quality audits of SLI and Supplier processes in the manufacturing of IVD, drug, and biologics products. The person in this position has a strong background in the pharmaceutical industry and will review and recommend audit / compliance related policies / procedures as well as evaluate impending regulations, guidelines and industry standards, and their impact on the Quality Audits for the SLI. This position requires frequent travels to Tecate, Mexico manufacturing site which may include overnight stays. Essential Duties: Plans and conducts Quality audits, as lead or co-auditor. Audits include internal sites in US and Mexico, and supplier audits. Responsible for identifying, documenting, and distributing audit observations/findings and issuing audit reports. Reviews & approve corrective action plans and tracks corrective action plan until completion. Conduct follow-up audits as needed. Provides timely written reports to inform management of SLI’s Quality/Regulatory compliance status. Prepares company sites for government regulatory agency visits to include local, state, federal, and foreign government agencies; participates on inspection team. Performs Quality Audit training and provide training to guest level auditors. Responsible for the development and revision of QA Audit SOPs, compliance tracking tools and audit worksheets to improve processes and procedures. Responsible for SmartAudit electronic system and follow-up processes. Requirements: BA/BS in Health/Life Sciences or equivalent work experience. A minimum of 4 years of industry experience in the quality field. A minimum of 2 years experience in the biomedical industry. A minimum of 3 years previous audit experience, both internal and supplier audits required. Certified quality auditor (CQA) or Certified Biomedical Auditor (CBA) or equivalent strongly preferred. Demonstrates a thorough knowledge of cGMP and ISO 13485 regulations and guidelines. Excellent written and oral communication skills and interpersonal skills. Ability to effectively manage multiple projects. Title: HVAC Maintenance Technician Department: Facilities Location: Santee, CA Schedule: Mon-Fri, 1st Shift Description: Works with minimal general supervision to perform repairs and routine maintenance in a safe, timely and professional manner to maximize the availability of all SLI assembly, production and packaging equipment, and facilities. Cleans, lubricates, adjusts, paints, restores, modifies and inspects equipment and facilities as directed by the Maintenance Manager and the maintenance schedules. Performs clerical duties as required to facilitate the ordering of parts and supplies, and the creation and maintenance of equipment history files. Records repair and maintenance activities in the appropriate equipment history files and reports the usage of spare parts and supplies to help keep an adequate supply of critical items. Works primarily to perform repairs and routine maintenance to SLI Lyophilizer Equipment, Refrigerators and Freezers and HVAC Equipment. Activities include but are not limited to aligning compressors and motor shafts, evacuating piping systems, replacing liquid line filters, air duct filters, changing compressor system oils, trouble shooting inadequate system operation, repairing leaks in piping systems, adding and reclaiming refrigerants, maintaining water towers and cleaning condensers and evaporators. Performs any other duties related to refrigeration and HVAC as required. Also, works with compressed gases, vacuum systems and pumps, hydraulics, pneumatics, mechanics, electrical, plumbing, structural, welding, building construction, lighting, test equipment and meters. Works on centrifuges, mixers, purification systems, telecommunications systems, pouchers, cartoners, box tapers, printers, air compressors and pneumatic systems, plastic sealing machines, heat tunnels, conveyors, forklifts, pallet jacks, hoists, industrial wiring and power distribution systems, dehumidifiers, filters, and any other as directed by the Maintenance Manager. Requirements: High school diploma or equivalent required. Possess a Universal EPA Certificate as evidence of formal Refrigeration and HVAC Training. Possess evidence of current training in the Industrial Maintenance field. Ability to comprehend, read, write and speak the English language fluently. Title: Purchasing Manager Department: Purchasing Location: Santee, CA Schedule: Mon-Fri, 1st shift Description: To oversee the day to day operations and personnel directly under his/her supervision. Manages, controls and directs Purchasing. To adhere to and follow all ISO 9001 standards and GMP’s and serve as a model for compliance to regulations and standards in all aspects of the job. To develop ideas and procedures to work towards continual process improvement. To support production and activities of the company in an efficient and timely fashion. Requirements: College Degree or equivalent work experience and 4 to 6 years working experience in Purchasing, Biotech background preferred, 5+ years supervisory experience required, APICS or CPM certification preferred, High school diploma and general college level courses, Excellent oral and written communication skills, general personal computer knowledge, intermediate skills in Microsoft Word, Excel and Outlook and clean driving record. Title: Manager, Regulatory Affairs Department: QA & RA Location: Santee, CA Schedule: Mon-Fri, 1st Shift Description: Ensure that Scantibodies obtains and maintains all regulatory approvals of products and facilities. This person is a key driver of change within Scantibodies and is heavily focused on Improvements to products and processes. Experience must include 510K filings for in-vitro diagnostic devices or medical devises, Submission of pre-IND, IND, NDA/BLA applications for drugs and biologics, developing a regulatory strategy for the regulated products which ensures compliance with regulations and marketability of products. Management of Department personnel. Requirements: Bachelors Degree, minimum of 7 years experience in regulatory affairs in similar industry, knowledge of GMP/QSR and ISO international regulations and standards which apply to SLI. Computer literate in MS Word and Excel and possess excellent communication skills. Title: Procurement Specialist Department: Purchasing Location: Santee, CA Schedule: Mon-Fri, 1st Shift Description: To obtain supplies, raw materials and services at the highest quality, most competitive pricing and in a timely fashion to support company activities. To search out, cultivate and maintain relations with suppliers who can provide the highest level of quality, technical support and competitive pricing. To adhere to and follow all ISO 9001 standards and GMP’s and serve as a model for compliance to regulations and standards in all aspects of the job. To develop ideas and procedures to work towards continual process improvement. To support production and activities of the company in an efficient and timely fashion. Requirements: 5 to 10 years general purchasing experience, Biotech background is preferred, CPIM or CPM certification not required but preferred, High school diploma and general college level courses, Excellent oral and written communication skills , General personal computer knowledge, intermediate skills in Microsoft Word, Excel and Outlook. Title: Senior Formulations Chemist Department: DKM (Diagnostic Kit Manufacturing) Location: Santee, CA Schedule: Mon-Fri, 2nd Shift Description: Senior Chemist V position requires that the employee have an excellent understanding of scientific principles as well as strong technical skills for solving problems and working with complex R&D projects. This position is necessary for assay development, R&D optimization projects, manufacture of complex controls and standards, and troubleshooting for existing protocols and processes. Essential Duties: Familiarity with iodinations for all kit manufacturing which include ACTH, PTH and Calcitonin. This responsibility includes job order production and management, understanding of radiation and its effects, general knowledge of how radiation is used in IRMA assays. Research and Development for assay development, kit optimizations, controls and standards, etc. This can include studies involving stability of kit components or controls and standards, minimizing variances between production lots, optimizing component performance and assisting the R&D team as needed for project support. Troubleshooting and optimizing of existing protocols and processes for kits manufacture and the manufacture of controls and standards. Technical and mechanical responsibilities such as tube coating, plate coating, freeze driers, etc. Manufacturing of complex controls and standards, including but not limited to cancer antigen controls, serum protein controls, and multianalyte controls. Manufacturing of kit components such as ELISA and ICMA plates, standards, controls, conjugates, wash buffers, etc. Equipment Used: Laboratory Computer (Word, Excel, M2M) Tube Coater Gamma Counter ELISA plate coater Luminometer Plate/Tube Washer General Laboratory Equipment (i.e. pipettes, pumps, filling systems, etc.) Requirements: Minimum Bachelor’s degree in Biology, Chemistry or Biochemistry. Preferred MS in similar field. Scantibodies Laboratory is one of the world's largest manufacturers of medical diagnostic products. If you are a career minded, highly motivated individual and would like to join the Scantibodies team, please fill-out the job application below and send it with your resume and salary requirements to our Human Resources Department |