Specialist External Quality Assurance
North Wales, PA North Wales, PA Full-time Full-time Estimated:
$69.
9K - $88.
5K a year Estimated:
$69.
9K - $88.
5K a year 3 days ago 3 days ago 3 days ago Job Description The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.
Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release by means of risk-based quality oversight and on-site supervision, as appropriate.
Bring energy, knowledge, innovation and leadership to carry out the following job requirements Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented Oversee repackaging activities in the External Party Conduct routine analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements Track and monitor operational and quality performance of the external manufacturer/partner Assist the maintenance of retention samples, ship reagents and samples to support license and foreign registration; responsible for shipment under quarantine Support routine process validation; review and approve validation reports/tech transfer Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes Regular site visits to build relationships and monitor efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums Education:
Bachelor's degree.
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.
For more information about personal rights under Equal Employment Opportunity, 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts 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:
Not Indicated Valid Driving License:
No Hazardous Material(s):
na Requisition ID:
R249298 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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
$69.
9K - $88.
5K a year Estimated:
$69.
9K - $88.
5K a year 3 days ago 3 days ago 3 days ago Job Description The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.
Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release by means of risk-based quality oversight and on-site supervision, as appropriate.
Bring energy, knowledge, innovation and leadership to carry out the following job requirements Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented Oversee repackaging activities in the External Party Conduct routine analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements Track and monitor operational and quality performance of the external manufacturer/partner Assist the maintenance of retention samples, ship reagents and samples to support license and foreign registration; responsible for shipment under quarantine Support routine process validation; review and approve validation reports/tech transfer Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes Regular site visits to build relationships and monitor efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums Education:
Bachelor's degree.
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.
For more information about personal rights under Equal Employment Opportunity, 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Learn more about your rights, including under California, Colorado and other US State Acts 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:
Not Indicated Valid Driving License:
No Hazardous Material(s):
na Requisition ID:
R249298 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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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