Ashland Inc

QA Specialist

Ashland Inc • $80K — $95K *
Wilmington, DE 19805In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS in chemistry or biology or equivalent experience
  • 5-8 years of Quality Assurance experience in a regulated industry
  • Team player with collaborative skills
  • Proficient in Microsoft Office Suite
  • Experience with SAP and iLIMS
  • Knowledge of Laboratory cGMP, GLP, and Safety standards
  • Strong written and oral communication skills

Responsibilities

  • Maintain and improve site quality procedures and management system
  • Support compliance with ISO 9001 and cGMP standards
  • Ensure quality documents are accurate and audit-ready
  • Promote data integrity in testing and reporting
  • Prepare and maintain quality and regulatory documentation
  • Conduct internal audits and compliance reviews
  • Perform risk assessments and implement controls
  • Investigate deviations and recommend corrective actions
  • Support management of change and validation projects
  • Conduct supplier risk assessments and support qualifications
  • Evaluate raw materials for compliance
  • Review batch records and manage product release
  • Coordinate product stability programs and retesting
  • Maintain records for Halal and Kosher certifications
  • Provide regulatory support for site products
  • Respond to quality-related customer inquiries
  • Set up new products in iLIMS
  • Support qualification of new laboratory equipment
  • Monitor quality metrics and analyze trends
  • Collaborate with cross-functional teams
  • Support quality and safety improvement initiatives

Benefits

  • Opportunity to work in a significant role within a visible team
  • Engagement in continuous improvement initiatives
  • Exposure to a variety of quality and regulatory processes
  • Collaboration with cross-functional teams
  • Support for professional development and training opportunities
Full Job Description
Ashland has an exciting opportunity for a QA specialist to join our Life Sciences, Quality and regulatory team Ashland Specialty ingredients G.P. business at our Wilmington aquarius manufacturing location. This is a very visible, significant role within the Company and the Quality and Regulatory function. This position will report to Quality Manager on the site.

Key responsibilities include, but are not limited to:
  • Maintain and continuously improve site quality procedures and the quality management system.
  • Support compliance with ISO 9001, current Good Manufacturing Practices (cGMP), and applicable site quality standards.
  • Maintain accurate, controlled, and audit-ready quality documents in accordance with good documentation practices.
  • Promote data integrity and uphold ethical standards in testing, research, and reporting.
  • Prepare, update, and maintain quality and regulatory documentation, including Standard Operating Procedures (SOPs), work instructions, and Drug Master File support documents.
  • Conduct internal quality and cGMP audits, gap assessments, and compliance reviews.
  • Perform risk assessments to identify potential hazards, evaluate compliance risks, and implement appropriate controls.
  • Investigate deviations, out-of-specification results, and customer complaints; identify root causes and recommend corrective actions.
  • Support management of change activities and quality-related validation projects.
  • Conduct supplier risk assessments and support supplier qualification and approval activities.
  • Evaluate raw materials for quality and regulatory compliance.
  • Review batch records and complete final product release activities in iLIMS and SAP.
  • Manage the product stability program, including sample coordination, data review, and documentation.
  • Coordinate raw-material and finished-product retesting as required.
  • Review product compliance against applicable compendial and global monograph requirements.
  • Maintain records and coordinate submissions for new Halal and Kosher product certifications.
  • Provide regulatory intelligence and documentation support for site products and initiatives.
  • Respond promptly and accurately to quality- and regulatory-related customer inquiries and documentation requests.
  • Set up new products in iLIMS and maintain accurate product master data.
  • Support qualification of new laboratory equipment and associated documentation.
  • Provide backup support to the Quality Control laboratory and inspect samples to verify consistent product quality.
  • Monitor quality metrics, analyze trends, and communicate findings to support informed decision-making.
  • Identify potential sources of error and recommend practical improvements to strengthen quality, reliability, and efficiency.
  • Collaborate cross-functionally with laboratory, manufacturing, regulatory, supply chain, and other site teams.
  • Support quality and Environmental, Health, and Safety good-catch programs and related improvement initiatives.

In order to be qualified for this role, you must possess the following:

  • BS in chemistry or biology or equivalent years of experience.
  • At least 5 to 8 years Quality Assurance experience in a regulated industry.
  • Ability to work as part of a team.
  • Competency in the use of Microsoft Office Suite.
  • Experience with SAP and iLIMS.
  • Knowledge of Laboratory cGMP, GLP and Safety.
  • Strong written and oral communication skills with ability to read, interpret, and report data.

About Ashland Inc

Ashland Global Holdings Inc. is a global specialty chemicals company that provides innovative solutions to customers in a wide range of consumer and industrial markets, including architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceutical. Through our three business units - Ashland Specialty Ingredients, Ashland Performance Materials and Valvoline - we use good chemistry to make great things happen for customers in more than 100 countries.
Learn more about Ashland Inc
Size
3,800 employees
Market Cap
$5.7 billion
Industry
Business Services
Net Income
-$484 million
Founded
1924
5 Year Trend
+0.7%
Revenue
$2.3 billion
NASDAQ
ASH
* Ladders Estimates

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