Senior Quality Assurance Associate
We are currently seeking an experienced senior quality assurance associate to act as a manufacturing site quality assurance representative. General responsibilities include reviewing quality records/documents; interactions with other departments to ensure compliance with internal procedures and applicable external regulations; and customer inquiry/complaint monitoring and facilitation of resolution. Previous experience working in a regulated manufacturing environment is required. Candidates must possess a high level of interpersonal communication skills and the ability to work effectively and courteously in a multifunctional, start-up environment. This is a full-time position and benefits are offered. Responsibilities and Duties •Review manufacturing records for accuracy and compliance with internal procedures. •Review and approve nonconformance and deviations with approval authority as designated by management. •Regularly provide quality assurance guidance to the site. •Conduct incoming material inspections and releases. •Review and print labeling materials for production as needed. •Involved with quality issues and actively pursue timely, compliant closure and documentation of all events and investigations. •Act as the primary point of contact for customer inquiries and complaints, facilitate investigation, and ensure prompt resolution with customer. •Apply change management utilizing a risk-based approach. •Review and understand analytical data. •Serve as a back-up for inventory/sales/purchasing system transactions. •Participate in multi-functional project teams, as necessary. •Perform other related work as assigned. Minimum Requirements/Qualifications •BS in a relevant science or technical discipline. •5+ years working in a regulated environment in a quality or regulatory capacity. •Comprehensive understanding of basic scientific principles and biotech manufacturing processes. •Comprehensive understanding of and experience with GMP and ISO regulations. •Able to communicate technical matters clearly and professionally while guiding teams to compliant, creative solutions. Able to communicate clearly and firmly when noncompliant or potentially non-compliant situations are identified. •Able to work in a fast-paced environment handling multiple priorities with attention to meeting deadlines while working effectively and efficiently. •Willingness to think outside of the box and adapt industry best practices and trends to our small but growing business. •Highly organized with exceptional written and verbal communication skills. Must be fluent in English (written and spoken). •Ability to problem solve with several variables in a methodical and careful manner. •Strong functional proficiency using Windows, Word, Excel and PowerPoint as well as the ability to quickly learn various job-specific computer applications. •Ability to work with colleagues, supervisors, vendors, and customers as needed. •Ability to be flexible and adaptable, willingness to help when needed. •Reliable attendance mandatory. •Able to walk and stand for extended periods of time on a variety of hard surfaces. •Able to work in a warm, cold, or dry environment in a manufacturing production setting with exposure to working near moving mechanical parts. •Must be authorized to work in the United States •Must be willing to submit to a pre-hire background check.