Quality Specialist 2 at BioReliance Corporation

Rockville, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

50.0

Posted On

01 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Auditing, Regulatory Compliance, Documentation Review, Trend Analysis, Client Audits, Communication, Interpersonal Skills, Collaboration, Problem Solving, Flexibility, Agility, Data Integrity, GMP, GLP

Industry

Biotechnology Research

Description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The Quality Specialist 2 contributes or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of work. This role performs a variety of tasks within the Quality Assurance department including conducting audits and review/approval of various types of regulated documentation. Job duties include: Shift: Monday-Friday 12:00pm to 8:30pm includes a shift differential Receives guidance from senior roles while independently solving low-complexity problems by analyzing information and selecting appropriate solutions. Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records. Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis. Review and approve validation files for assays, as well as minor, major, and critical impact deviations and OOS records. Conduct trend analysis for deviations and review / approve applicable CAPA records. Conduct laboratory inspections to include commissioning and/or internal audits. Provide support for client regulatory submissions, client audits and supplier audits. Review and approve client and supplier quality agreements. Involves up to 10% travel Who You Are Minimum Qualifications: Bachelor’s Degree in Biology, Chemistry, or other science discipline with 2 + years of Quality Assurance experience in a GxP environment OR Associate Degree in in Biology, Chemistry, or other science discipline with 4 + years of Quality Assurance experience in a GxP environment OR High School Diploma or GED with 6 + years of Quality Assurance experience in a GxP environment Preferred Qualifications: Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity). Demonstrates strong communication and interpersonal skills, acts ethically to ensure quality in personal and teamwork, exhibits flexibility and agility, and takes responsibility for meeting turnaround times. Collaborates with cross-functional teams and builds networks within QA and Operations to identify and implement improvements. Pay Range for this position: $30.00 - $50.00. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

The Quality Specialist 2 is responsible for conducting audits and reviewing various types of regulated documentation within the Quality Assurance department. This includes approving standard operating procedures, study files, validation files, and conducting laboratory inspections.