Job Description

The Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. This person will also review and approve documentation accompanying the disposition of excipients, components, and critical supply items for sterile or non-sterile use to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. Collaborates with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notifies relevant management of unresolved issues/trends.

The Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure clinical drug product manufacture is in compliance and will gain competency in their responsibilities. Primary responsibilities include but are not limited to the following:

• Perform GMP review of in-coming material documentation and disposition for use in clinical supplies including vendor provided documentation, incoming inspection packet, deviations and change management records, etc.

• Perform GMP documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.

• Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables.

• Accountable for all assigned projects and communication of status to the Management team.

• Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system development and approval.

• Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality.

• Adhere to cGMPs and SOPs.

• Identify and implement continuous improvement initiatives and action plans.

• Assist in preparations for regulatory agency inspections.

Education Minimum Requirements:

• B.S. in appropriate Science or Engineering discipline (chemistry, biology biochemistry, microbiology).

Required Experience and Skills:

• Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, interpersonal and conflict resolution skills.

• Basic understanding of GMPs and Good Documentation Practices and related drug regulation requirements, including European Union.

• Ability to manage multiple priorities and projects simultaneously.

• Attention to detail, flexibility, and an awareness of production and associated quality problems.

Preferred Experience and Skills:

• Experience in Pharmaceutical or related industry in quality control, quality assurance, manufacturing, clinical development or clinical supply areas.

• Excipients and components release requirements/testing.

• Non-sterile and/or sterile drug product manufacture/testing.

• Knowledge of SAP.

• Problem-solving skills.

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.

GRACSJOBS

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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$83,100.00 - $130,900.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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:

Yes

Hazardous Material(s):

N/A