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Quality Specialist

4 months ago

Arvada, Colorado, United States Merck Full time

Job Description

Primary activities include, but are not limited to:

  • Becomes fully trained in our company's Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
  • Learns cGMPs, the manufacturing process, and our company's quality systems.
  • Performs audit of process documents/log books to ensure completeness and accuracy for assigned End to End. Maintains any tracking databases and logs associated with this review.
  • Reviews documents including batch records, log books, and critical site review packets.
  • Coordinates with Production to discuss, resolve, and eliminate documentation defects.
  • Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures.
  • Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
  • Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
  • Collaborates with IPT members to investigate deviations on production floor during shift.
  • Works with necessary groups within the End to End to resolve outstanding issues with process documents/log books and GMP walkthrough inspection observations.
  • Reviews emergency stamps/hand stamps entered into batch records.
  • Ensures proper identification of release status and control to materials through maintenance of batch and stock status in SAP and through physical tagging of material as required.
  • Completes monthly internal quality audits of the manufacturing areas in the End to End.
  • Performs Quality review of new and updated Master Batch Records (MBRs).
  • Provides coaching and mentoring of manufacturing managers and operators completing documentation.
  • Assists with training of incoming personnel.
  • Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, qualification activities, and inspection support.


Education Minimum Requirement:

  • Bachelor's degree. Technical emphasis in a scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by relevant experience.

Required Experience and Skills:

  • At least 1 year of experience in a quality, operational, or technical function supporting manufacturing.
  • Evidence of leadership skills coupled with good oral 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 quality control.
  • Basic understanding of cGMPs and or regulatory requirements as they apply to the pharmaceutical field or a related area.

Preferred Experience and Skills:

  • Familiarity with vaccine and/or pharmaceutical processing.
  • Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
  • Aseptic gowning will be required

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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.

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, generally Tuesday, Wednesday and either Monday or 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".

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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/1/2024

*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.

Job Posting End Date:06/01/2024

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:R296169