Specialist, Quality Assurance - Change Control
- Wilson, NC
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, defect resolution in packaging operations and control of material throughout the plant, plant investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, and other Quality Assurance related functions as required. The Specialist, Quality Assurance is the primary source of advice, guidance and input regarding quality issues for production personnel and our Company divisional and inter-site customers.
The successful candidate must demonstrate strong leadership capability and work independently to ensure job assignments are conducted in a timely and reliable manner to meet production demands, and be knowledgeable in regulatory requirements to ensure site compliance with all expectations.
- Provides Quality oversight, strategy input, and concurrence on site level change controls (PCRs). Performs, interprets, reviews, and approves equipment/process validation/qualification activities and provides review and approval of change control documents
- Provides Quality Assurance review and approval of GMP-related SOPs and assist in the development of procedures to improve compliance status of Wilson operations
- Defect resolution, including use of statistical methods, and control of material throughout the plant site
- Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition
- Ownership and completion of Quality related investigations
- Performs a variety of regulatory document reviews and participates on PCR committee and sets Quality Operations requirements
- Participates in project and PCR strategy meetings in support of Quality Master Data builds and maintenance
- Provides shift coverage on as needed basis
- Participates in the implementation of new programs/regulations/divisional processes at the site
- Identifies continuous improvement (business and compliance excellence) opportunities and through partnership and engagement with other functional groups, implements changes to processes
- Maintains 5S organization and identifies improvement opportunities
- Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
Education Minimum Requirements
- Bachelor of Arts or Science degree (preferably in Science or Engineering)
Required Experience and Skills
- Three (3) years experience in a GMP pharma manufacturing facility in a function promoting batch release / change control / record & documentation reviews / investigations / corrective actions / quality system management
- Must possess highly developed written and verbal communication and teamwork skills
- Additionally must have strong attention to detail, problem solving skills, and proficient in time management
- Advanced knowledge and ability to operate information systems (SAP COMET and TrackWise preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
- Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
- Ability to independently reply to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
- Minimum of three (3) years in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
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.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
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.
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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.
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