Job Description

Job Description

Quality Engineering (QE), part of Durham's Quality Assurance (QA) organization, in Building 160 (B160) is seeking a Quality Specialist (P2) that will support B160's start-up and transition to commercial manufacturing of Tice © Bacillus of Calmette and Guerin (BCG).

The successful candidate will interact directly with Quality Operations (QO), Shop Floor Quality Assurance (SFQA), Sterility Assurance (SA), Engineering Maintenance Site Services (EMSS), and Warehouse Operations, and Quality Assurance colleagues as directed in support of Project Flash.

This position will support the technical roles of Quality in collaboration, review, and approval of cGMP documentation in the following areas:- qualification protocols, procedures & work instructions, calibration & preventive maintenance program, change management, housekeeping & sanitization, gowning qualifications, and sterility assurance compliance, and facility environmental requalification activities.-

Position Responsibilities :-

• Report to the Quality Assurance (QA) organization, independently support QA/QE startup and transition to commercial manufacturing assignments.-
  
• Support Sterility Assurance (SA) Environmental Monitoring (EM) monthly and annual trending report preparation using GLIMS, SAP, IPI, MIDAS/MEDS, site procedures and divisional guidelines (GDL).
  
• Assist with B160 oversight of Environmental Monitoring (EM), Airflow Visualization studies (AVS), Aseptic Process Simulations (APS), and semi-annual HEPA recertification activities.
  
• Support B160 aseptic gown program.
  
• Provide Quality cGMP documentation support to EMSS, Warehouse, Sterility Assurance, SFQA, and QO labs (e.g., SOPs, logs, CAPAs, QNs).
  
• Support technical quality reviews of cGMP documentation for sustained compliance with QMS guidelines.
  
• Support technical quality review of critical utilities and facility environmental control systems through periodic equipment reviews and performance trending.
  
• Support QO Lab, Sterility Assurance, EMSS, and Warehouse pre-approval inspection (PAI) readiness activities.-
  
• Support QO Lab, Sterility Assurance, EMSS, and Warehouse process change control activities.-
  
• Support compliance of Building 160's policies and procedures that promote Permanent Inspection Readiness (PIR).-
  
• Participate in periodic site GEMBAs (walk-downs) as part of on-going Quality and Safety compliance.-
  
• Escalate and collaborate quality and compliance issues as needed through established Tiers.-
  

Education Minimum Requirement :-

• Bachelor's degree (BA/BS) in mechanical engineering, systems engineering, chemical engineering, biochemical engineering or other related engineering or science discipline.
  

- Required Experience and Skills: -

• Minimum of two (2) years of experience in the pharmaceutical industry, technical services, or quality assurance/operations.
  
• Strong verbal communication and technical writing skills.-
  
• Independent, self-directed, with strong critical thinking skills.-
  
• Strong customer focus.
  

Preferred Experience and Skills: -

• Experience with Current Good Manufacturing Practices (cGMP) aseptic gowning, clean room environments, environmental monitoring, and housekeeping procedures.
  
• Strong current Good Documentation Practices (cGDP) skills.
  
• Experience utilizing cGMP Quality Manual Standards (QMS) and Site Standard Operating Procedures (SOPs) as part of operational compliance.-
  

• Experience with pharmaceutical equipment or utility systems.
  
• Experience with EM sampling Global Laboratory Information Management System (GLIMS),
  
• Experience participating in Quality Risk Assessments (QRAs)
  

• Experience with calibration and maintenance databases (e.g., Spotfire, ProCal, Fiore).-
  

• Experience with Root Cause Analysis (RCA) and 8-Step problem-solving.
  

• Experience with cGMP document management systems (e.g., MEDS, KNEAT, Veeva Vault, IPI, CLUE, and SAP).-
  

Experience with MS Office software applications (Excel, PowerPoint, Word, OneNote, Teams, and Power BI)

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. - For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
02/18/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R334151

Job Tags

Permanent employment, Full time, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,

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