Golden, CO, 80402, USA
4 days ago
Quality Analyst
Job Title: Quality Analyst Job Description This position is responsible for completing quality assurance responsibilities such as document review and approval, assistance in quality events such as deviations, CAPAs, and change controls. Responsibilities + Handle deviations and testing-related investigations as needed. + Manage change controls. + Learn and follow established procedures and guidelines (SOPs) and communicate procedures inter and intra-departmentally in accordance with current Good Manufacturing Practices (cGMP). + Perform quality checks on batch records to prepare products for batch release. + Assist with data entry, trending, and review. + Manage special projects ensuring tasks are completed in conformance with business and regulatory requirements. + Ensure compliance with federal and state laws, as well as company standards and specifications. + Perform other duties as required. Essential Skills + Experience working in a GMP testing facility. + Experience working under FDA guidelines. + Excellent communication skills; both verbal and written. + Proficiency with Microsoft Office Suite (Word, Excel) and the ability to utilize various software programs. + Strong work ethic and attention to detail. Additional Skills & Qualifications + High School Diploma required. + Associates Degree preferred. + Experience working in the Pharmaceutical Industry. + Experience working in a Federally Regulated Facility. + Must be able to lift up to 50 lbs. frequently throughout the day. + Must be able to work in various positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking for prolonged periods of time. + Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned. Work Environment This is an on-site position, Monday to Friday, from 8:30 AM to 5:00 PM, located at 150 Capital Drive, Suite 430, Golden Colorado. The quality team consists of approximately 5 people, with about 10 people at the research facility. The team-oriented environment includes a break room with coffee and tea, and EAP programs. Pay and Benefits The pay range for this position is $30.00 - $33.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Golden,CO. Application Deadline This position is anticipated to close on Mar 3, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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