Specialist, Quality

Job Description

Environmental Monitoring Quality Specialist

The Environmental Monitoring Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance and will train on and gain competency in their responsibilities for assigned End to End.

Responsibilities

• Become trained in the company's Quality SOPs, production SOPs as needed, SAP, and GLIMS functions as required by Environmental Monitoring Quality Specialists
• Learn and adhere to current Good Manufacturing Practices (cGMPs), the manufacturing process, the company's Quality Systems, and safety procedures
• Monitor environmental performance against specifications within classified areas
• Provide environmental support to manufacturing and testing areas as needed
• Quality review/approval of new and updated SOPs and Controlled Job Aids and ensures compliance with departmental procedures
• Actively participate in the Tier process to inform, escalate, collaborate across teams, and share and best practices
• Collaborate with IPT (Integrated Production Team) members in the identification and implementation of continuous improvement initiatives and action plans
• Aid in investigations into environmental excursions
• Aid in and support CAPA (Corrective Action and Preventive Action) development and participates in continuous improvement initiatives
• Author environmental project protocols and reports
• Aid and participate in aseptic process simulations
• Assist with training of incoming and existing personnel
• Cross train to support other functional quality areas including but not limited to environmental monitoring support and deviation management
• Actively participate within and provides support with internal audits and regulatory inspections

Position Qualifications :

Education Minimum Requirement:

• Bachelor degree in Microbiology or Biology is preferred | Candidates with BS in Chemistry, Engineering, Pharmacy, or equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting

Required Experience and Skills:

• Minimum one year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations
• Evidence of good verbal and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
• Attention to detail, flexibility and an awareness of production and attendant quality control problems
• Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields
• off shift and weekend support as needed

Preferred Experience and Skills:

• Familiarity with vaccine and/or pharmaceutical processing
• Aseptic gowning

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

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

Learn more about your rights, including under California, Colorado and other US State Acts

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".

The salary range for this role is
$85,600.00 - $134,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
No Travel Required

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
bls 2

Required Skills:
Adaptability, Aseptic Manufacturing, cGMP Compliance, Data Analysis, Decision Making, Documentation Review, Environmental Monitoring, Environmental Quality, FDA Regulations, Manufacturing Processes, Microbiology, Preventive Action, Process Manufacturing, Quality Inspections, Quality Operations, Regulatory Compliance, Regulatory Inspections, Regulatory Requirements, Technical Writing, University Education

Preferred Skills:

Job Posting End Date:
06/25/2025
*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:R354279