Quality Assurance Assistant
Primary Function
To perform record review of quality records and provide general support to QA team and QA Management
Essential Job Functions/Duties
Print and issue batch records
Review completed batch records, associated forms, and general forms for accuracy, completion, and GMP documentation.
Review and approve documentation associated with Biopsy receipt
Review and approve documentation associated with incoming materials
Compile and/or review data compiled for reports.
Maintain spreadsheets and databases using Excel and Access
Clerical functions such as printing, scanning, and filing of QA records and documentation
Assist with process improvement projects
Assist with training of other QA team members
Perform various computer applications on MS Office programs
Knowledge, Skills, and Abilities
Exemplifies Cook MyoSite Core Values
Maintain regular and punctual attendance
Must maintain company quality and safety standards
This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
Ability to work in collaborative and independent work situations and environments with minimal supervision
Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
Trainability
Must have effective verbal, written and interpersonal skills
Able to prioritize and operate proactively
Must maintain a high level of confidentiality
Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations
Computer, Technology, and Technical Skills & Abilities
Proficient knowledge of Microsoft Office software, and other general office equipment.
Education/Qualification Requirements
Associates degree in Life Sciences, Biomedical or related fields or 4 years of direct, relevant experience in cGMP environment to provide a comparable background
Experience Preferred:
Minimum of 1-3 years’ experience in cGMP background
Preferred Qualifications:
Knowledge of cGMP regulations and good documentation practices
Physical Requirements/Work Environment
Hybrid
Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
Physical Requirements:
Ability to conduct and hear ordinary conversation and telephone communication.
Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
Ability to work under specific time constraints.
Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
Visual and manual acuity for working with computers and equipment.
Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.
Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.
Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.
Option for Visa Sponsored Position:
Permanent Resident / US Citizen Only
Training Compliance:
Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.
At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.
