Quality Assurance Specialist

Company overview: ALPCO Diagnostics sells immunoassay kits (ELISA/RIA) as well as antibodies and recombinant proteins to the life science and medical diagnostic industries. Customer segments include clinical and hospital reference labs, Biotech and Pharmaceutical R&D labs and basic academic research labs.** This is an in-person position in Salem, NH. Applicants must be currently authorized to work in the United States. ALPCO is unable to provide employment visa sponsorship for this position now or in the future.Compensation: $55,000 - $70,000.00Position Summary: The Quality Assurance Specialist

Requirements

Degree in Chemistry or QualityPosition Summary: We are seeking an experienced and motivated individual to work closely with our quality department and manufacturing teams on product quality through review of batch records, confirming production matches procedures and performance meets specifications. Reporting to the Quality Lead, the Quality Assurance Specialist will be responsible for. The role requires experience in a biotech, pharm and/or medical device environment.Effective analytical skills, organizing skills with the ability to communicate and support high speed manufacturing.

Job Description

Label/Kit inspectionsKit final InspectionsRaw Material Inspection/ stickerComponent folder review/ sticker if neededDocumentation housekeeping/ filing/ updating/ scanning Consults manufacturing departments and Quality on process improvement.Assures compliant and complete product documentation, inclusive of Batch Records and that support successful and compliant product approval and release.Collaborate with subject matter experts across multiple functions to ensure quality and technical accuracy of content.Determines and/or recommends direction on technical product or manufacturing issues.Prepares and issues assigned quality reports.Adheres to policies and procedures. Exercises independent judgment in quality assurance related activities.Ability to influence cross functionally (warehouse and Operations) and within the manufacturing operation.Ensures positive, productive, and proactive relationships with associates.Self-driven, takes ownership and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives.

Qualifications

BS Chemistry, Quality, or related field with 5+ years experience or Master's degree in field with 3+ years experience or Doctoral degree in field with 0-2 years experience in development or manufacturing quality in research use, medical device, IVD or related field.Uses complete understanding and wide application of technical concepts, standards, and practices in chosen field and is expanding knowledge or related disciplines.Full knowledge of industry standards and Good Lab PracticesApplies analytical skills and independent judgement to develop innovative, practical and consistent solutions to a wide range of complex problems.Demonstrated ability to perform detail-oriented work with a high degree of accuracyWorking knowledge of U.S. and international regulations (QSR,ISO,GLP,cGMP)Experience working under pressure, prioritizing and multitasking quality issues in real timeExcellent oral and written communication skillsEffective team collaboration, influencing, and facilitation skills