Quality Specialist 2

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

13h•$30 - $50•Onsite

About The Position

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 10:00am to 6:30pm 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

Requirements

Bachelor’s Degree in Biology, Chemistry, or other science discipline with 2 + years of Quality Assurance experience in a GxP environment
Associate Degree in in Biology, Chemistry, or other science discipline with 4 + years of Quality Assurance experience in a GxP environment
High School Diploma or GED with 6 + years of Quality Assurance experience in a GxP environment

Nice To Haves

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.

Responsibilities

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.