Career Opportunities
|
Last updated on
|
|
|
Title: Therapeutic Manufacturing Manager Department: GEN Location: Tecate, Mexico Schedule: Mon-Fri, 1st Shift Description: Manufactures sterile injectable products by designing and developing methods; establishing priorities; supervising personnel. Essential Duties: Establishes manufacturing quality standards, methods, facilities, policies, and procedures by studying product requirements; obtaining engineering consultations; determining equipment and facility budgets. Establishes an organization structure by assigning responsibilities; delegating authority; recruiting, selecting, orienting, and training employees. Develops production plan by coordinating requirements with sales, engineering, procurement, and traffic departments. Completes production plan by establishing priorities; scheduling activities and employees; monitoring progress; revising schedules; resolving problems. Ensures operation of equipment by establishing preventive maintenance requirements; conferring with manufacturers; contracting for special maintenance services; maintaining equipment inventories; evaluating new equipment and techniques. Maintains manufacturing staff job results by coaching, counseling, and disciplining employees; answering grievances; planning, monitoring, and appraising job results. Achieves financial objectives by preparing the manufacturing and maintenance budgets; scheduling expenditures; analyzing variances; compiling and studying costs; initiating corrective actions. Prepares reports by collecting, analyzing, and summarizing information and trends. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; visiting other manufacturing facilities; participating in professional societies. Contributes to team effort by accomplishing related results as needed. Requirements: Must be Bi-lingual in Spanish. Current US Passport for daily travel into Tecate. Bachelors Degree with major in Science and a minimum of 5 years in Manufacturing. 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: 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: Calibration Specialist Department: Quality Assurance Location: Santee, CA Schedule: Mon-Fri, 1st Shift Description: Responsible for maintaining, developing, and improving the Environmental Monitoring and Calibration Programs in the USA and Mexico facilities. Coordinates schedules and, performs all aspects of calibration and environmental monitoring. Provides technical assistance for personnel regarding calibration protocols. Comprehends the role that calibration has in the laboratory and its effect on producing high quality products. Validates new areas and changes to the DI Water loop. Strives to make the job more efficient while maintaining compliance. Follow GMP’s, ISO 9001/13485 standards and all the applicable international and domestic regulations and standards in all aspects of the position. Assists in other departmental duties such as CAPA Program, Validation of new areas and equipment in both Santee Ca, and Mexico locations. Requirements: High School Diploma or equivalent required. Must have a minimum of 1 year experience in the calibration of the type of equipment used at SLI. Read and follow written and verbal instructions. Write clearly and legibly with good verbal communication skills. Practice good time management and organizational skills. Must be detail oriented and be willing to learn. Follow all safety policies at all times. Maintain confidentiality at all times. 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 |