Quality Specialist 2

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Merck Group’s Quality Specialist 2 in Rockville, MD is a full-time onsite QA role focused on reviewing and approving SOPs, batch records, study files, validations, deviations including OOS, CAPA trend analysis, and internal and client audits, with travel up to 10% and a 12:00 pm to 8:30 pm Monday through Friday shift with differential. Candidates hold a BS in biology or chemistry with 2+ years QA in a GxP environment, or an associate degree with additional QA experience, and have solid knowledge of FDA and EU regulations, data integrity, and strong communication plus cross-functional collaboration. Pay is $30-$50, benefits included; sponsorship is not offered. To apply, tailor your resume to QA in GxP, highlight SOPs, CAPA, and audits, and show US work eligibility.

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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.

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