goods. Superintend systems in place, to ensure great quality Responsible for investigating and responding to customer quality complaints/issues Checking with factories mid-production and on final product Lab Testing Signing off PO's Mid production and end of production testing Interacts with representatives from a variety of functional groups, including; design, testing, engineering, purchasing, and all production and inspection personnel in the assigned product or program area.
Requirements: Masters preferred Organized Familiar with ASTM Strong physics background Documentation/record keeping System solution oriented Company Benefits: Full Time Position Competitive Salary Fully Paid Medical Insurance 50% Coverage Dental Plan 50% Coverage Vision Plan Life Insurance Generous PTO Package Paid Holidays #ZR Job Posted by Applicant Pro
include, but are not limited to: Independently leads and supports comprehensive internal audits of GMP facilities or systems supporting clinical suppliesmanufacture, testing, storage, and distribution to ensure compliance to applicable regulations, policies, and procedures.
Issues report summarizing findings and tracks resulting CAPAs to satisfactory closure in order to maintain appropriate risk posture for the site. Notifies relevant management of unresolved issues or trends. Maintains an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Provides support for the preparation and execution Health Authority Inspections.
Proactively identifies, develops and implements opportunities for work/process improvement and efficiency. Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
Develops and maintains metrics and key performance indicators to measure trends and improve quality performance. Presents outcomes to management and governing Quality Councils. Leads and supports GMP readiness activities for new manufacturing facilities, laboratories and support areas. Promotes a culture of quality and operational excellence. Proactively identifies areas for improvement and work across multiple organizations to influence
and implement solutions. Education: Required: Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline Preferred: Advanced degree Required: Minimum 5 years of experience in medical or related industry Minimum 2 years experience leading internal or external GMP auditinteractiontensive knowledge of FDA and EU GMP regulations as well as ICH guidelineinteractioncellent attention to detail Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering Experience participating in US and EU health authority inspections.
Strong leadership and collaboration skillinteractioncellent verbal and written communication and presentation skills Proficiency with digital tools and computer applications; knowledge and competency in Power Point, Excel, and Word Ability to independently manage multiple priorities and projects Preferred: Familiarity with R&D or clinical supply areas and processes Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines. Active medical Ingredient experience and knowledge of ICH Q7 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 separationpackage, 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, interaction, interactionual 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: $97,680.00 - $153,700.00Available 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): None Requisition ID: R271252PDN-9acdb7a9-f5bc-4993-8a92-0375d80c50cd
