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SalaryJob Description
The Rahway based Specialist, Global Development Quality Operations - API, is responsible for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release and maintenance in support of our company's clinical supply programs. This person will also review and approve documentation accompanying the disposition of API materials (including new modalities) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Performs 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.
The Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API (including new modalities) manufacturing and testing is in compliance and will gain competency in their responsibilities.
Primary responsibilities include but are not limited to the following:
Perform Quality Assurance activities related to API (including new modalities) manufacturing in a complex, clinical supply development. Review and/or approve GMP documents.
Ensure all API (including new modalities) are manufactured in compliance with cGMP and regulatory filings.
Perform quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.
Conduct auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
Accountable for all assigned projects and communication of status to the Management Team.
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, Quality Assurance, regulatory, etc. at all levels.
Establish, educate, and enforce standard operating procedures (SOPs) required under GMP.
Develop/update SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system document approval.
Other duties as assigned by manager for the flexible functioning of the work group.
Support metrics by summarizing findings during documentation reviews.
Maintain a state of readiness for and participate in audits and inspections.
Consult on quality risk management activities as requested
Support continuous quality improvement initiatives and action plans.
Perform document management activities such as cataloging records for long term document storage according to retention policies.
Education Minimum Requirements:
Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, 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.
Ability to manage multiple priorities and projects simultaneously.
Attention to detail, flexibility, and an awareness of production and associated quality problems.
Ability to work in a dynamic environment with rapidly changing needs.
Ability to work across functional and sites, with all levels of staff and management.
Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.
Preferred Experience and Skills:
Experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
Experience in one or more functional areas such as Quality Assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory.
Basic understanding of GMPs and Good Documentation Practices and related API regulation requirements.
Knowledge of R&D or clinical supply areas and processes.
API knowledge and experience.
System knowledge of Veeva, SAP, Trackwise.
NOTICEFORINTERNALAPPLICANTS
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 - $130,900.00Available 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
YesHazardous Material(s):
N/A
Requisition ID:R286821
