Specialist, External Quality Assurance - Product Quality Manager #Ncp1

Merck & Co., Inc. Lansdale , PA 19446

Posted 4 weeks ago

Job Description:

Overview:

The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, 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 of (API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals) by means of risk-based quality oversight and on-site supervision, as appropriate.

Primary Activities may include, but are not limited to the following:

  • 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 licensure 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

Background:

  • Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

  • Previous experience in the pharmaceutical industry with some knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred

Required Skills:

  • Solves range of straight forward problems

  • Receives moderate level of guidance and direction

  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

  • Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed

  • Explains information and persuades others in straightforward situations

  • Accountable for technical contribution to project team or sub-team; may manage/lead a small project team

  • Ability to work across boundaries; developing interpersonal, relationship building and leadership skills

  • Communicates easily in English both verbally and in writing

  • Knowledge of External Manufacturing management, supply chain, and operations

  • Lean Six Sigma Systems training an advantage

  • Fluent in English language (reading, writing and speaking)

Travel:

  • Ability to travel up to 10% of the time

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Control Inspector V

Cobham

Posted 2 months ago

VIEW JOBS 8/12/2020 12:00:00 AM 2020-11-10T00:00 Quality Control Inspector V Lansdale-PA-US Founded in 1934 by aviation innovator Sir Alan Cobham, our values of Trust, Talent and Technology have driven us to become a global leader in state-of-the-art aerospace and defense systems. It's the insights of our innovators today that will secure our collective future. Innovators like you! Cobham is searching for a Quality Control Inspector V. The position performs visual, mechanical, functional, dimensional or electrical inspection of a variety of raw materials and products in the production assembly process through to final system assembly. Performs inspection tasks involving the use of a wide variety of test instruments and equipment to measure values and record functional operation of components, equipment, systems, supplies and materials. Determines acceptability, and identifies and recommends disposition of defective items in accordance with established procedures. SPECIFIC RESPONSIBILITIES: Works from blueprints, drawings, process sheets, engineering change orders and written and verbal instruction to inspect mechanical parts, subassemblies and assemblies against required quality standards (i.e., hardness, thickness, painting, plating, etc.). Utilizes standard precision tools such as micrometers, verniers, optical comparator, coordinate measuring machines and gauges to measure dimensions where tolerances may be exacting and parts are intricate in nature. Perform calculations to determine angles, tolerances, dimensions and other specified measurements. Identifies defects and calculates defect rates against specified control limits. Inspects and tests parts, subassemblies and assemblies after rework, modifications or repairs to verify defects have been corrected and ensure continuity to drawings, prints, etc. Performs simple setups of inspection equipment. Applies inspection stamp for acceptability of mechanical parts, subassemblies and assemblies. May perform final inspection prior to customer acceptance to ensure end product meets customer requirement. Interfaces with engineering regarding technical issues and problem resolution. May conduct quality audits to confirm processes are being accurately completed. May perform field return evaluations to ensure returns are repaired within quality guidelines. Work directly with machinists to correct non-conforming parts Write CMM programs for complex part inspection Mentor junior level inspectors Provide technical inspection leadership to management, colleagues, and customers Performs other duties and responsibilities as required. BASIC QUALIFICATIONS: High School Diploma (or equivalent) 10 years related experience in mechanical inspection 6 years CMM experience in mechanical inspection In order to be considered for this opportunity, you must be eligible to obtain and maintain security clearance, which requires USA Citizenship PREFERRED QUALIFICATIONS Associates Degree or Technical Certification Experience with AS9100D or equivalent Excellent communication Excellent critical thinking Experience using Mitutoyo CMM (MCOSMOS) Experience in defense contract or similar industry Microsoft Office Suite proficiency Experience working in a machine shop If you are authorized to work in the United States, then we encourage you to apply. We are unable to sponsor work visas. Cobham is one of the world's leading companies engaged in the development, delivery and support of leading-edge aerospace and defense systems in the air, on land and at sea. Our clients and partners trust Cobham to deliver the mission-critical technology they need, and we trust our employees to draw on their ingenuity and passion to deliver those solutions. This leads to an empowering culture for our people. Our Leadership team is open, sharing plans for the next five years, driving retention by offering demanding, exciting work, and providing full guidance and mentoring. Employment Transparency: Cobham is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population. It is the policy of Cobham to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or genetic information. Cobham will refrain from discharging, or otherwise discriminating against, employees or applicants who inquire about, discuss, or disclose their compensation or the compensation of other employees or applicants. The EEO is the Law poster is available here and the poster supplement is available here. The Pay Transparency Policy is available here. Cobham Advanced Electronic Solutions is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation due to a disability for any part of the employment process, please send an e-mail to CAEScareers@cobhamaes.com and let us know the nature of your request and your contact information. Cobham Lansdale PA

Specialist, External Quality Assurance - Product Quality Manager #Ncp1

Merck & Co., Inc.