Quality Assurance Specialist
ALPCO
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 following.
Job description
Position 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 following.
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 inspections
- Kit final Inspections
- Raw Material Inspection/ sticker
- Component folder review/ sticker if needed
- Documentation 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 Practices
- Applies 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 accuracy
- Working knowledge of U.S. and international regulations (QSR,ISO,GLP,cGMP)
- Experience working under pressure, prioritizing and multitasking quality issues in real time
- Excellent oral and written communication skills
- Effective team collaboration, influencing, and facilitation skills
Requirements
- BS in Chemistry, Quality, or related field with 5+ years experience, or Master's degree with 3+ years experience, or Doctoral degree with 0-2 years experience
- Experience in development or manufacturing quality in research use, medical device, IVD, or related field
- Experience in a biotech, pharm and/or medical device environment
- Full knowledge of industry standards and Good Lab Practices
- Working knowledge of U.S. and international regulations (QSR, ISO, GLP, cGMP)
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy
- Excellent oral and written communication skills
- Effective team collaboration, influencing, and facilitation skills
- Ability to work under pressure, prioritizing and multitasking quality issues in real time
Company overview
ALPCO (American Laboratory Products Company, Ltd.), founded in 1991 and headquartered in Salem, New Hampshire, is a global developer and provider of specialty diagnostic solutions focused on infectious and gastroenterological diseases. The company supplies instrument platforms and assays for life sciences, clinical research, and diagnostics, spanning immunoassays (ELISA, RIA, chemiluminescence, and immunoturbidimetric formats) as well as molecular diagnostics. ALPCO serves research and clinical laboratories with high-quality, user-friendly, and reliable testing solutions, and has expanded its portfolio into allergy and immunology testing. In 2022 ALPCO merged with GeneProof a.s., forming a global diagnostics company, and has partnered with Dynex Technologies and Gold Standard Diagnostics to deliver automated multiplex and benchtop ELISA systems. In December 2023 the company announced FDA 510(k) clearance for its Calprotectin Immunoturbidimetric Assay, followed by a European commercial launch in 2025. ALPCO operates with roughly 80 employees across North America, Europe, and Asia.