Company Information: A leading CMO for specialty chemicals in the Pharma, Agriculture, and Industrial markets with presence in North America and Asia, the company brings extensive R&D, logistics, procurement, and regulatory excellence to its clients. The company culture is family oriented and built on passionate employee engagement in an atmosphere of competence and mutual respect. The team oriented, can-do culture extends beyond expected boundaries as the company is very active in various community outreach projects such as Ronald McDonald House and others.
Benefits & Features:
Competitive compensation with bonus plan
Full employee health, dental, and vision (company pays 100% for employee)
Company paid life insurance
Consistent annual merit increases
Possible relocation for the right candidate
Your Role with the Company:
Assists in the development and implementation of Quality programs for the organization
Ensures operating manuals and procedural documents stay current when changes occur
Takes a lead role in the Quality Program. Works to maintain the Quality Metrics, complaint resolution, and customer inquiries
Responds to inquiries from customers and facilitates the completion of product related documentation.
Requires a bachelor's degree
Reports into the QA and Compliance Manager. One or two trips per year to Asia are possible but other travel will be minimal (10-15%) and driven by business need
Working knowledge of assigning ITC HTS codes in chapters 28, 29,30,33
Prior CDR filing experience or other CDX activities with EPA
DOT certified within first 90 days
Working knowledge of IATA, IDGM hazardous code assignments.
In depth experience with c-GMP/ICH-Q7 regulations in production and lab settings to support customer and company DMF, ANDA filings
Understanding of REACH regulations
Ability to prepare US and European Union SDS and labels compliant with GHS regulations
Ability to interpret Federal Register, use of CFR as it applies to chemical regulations
Working knowledge of all sections of TSCA
Exposure to China regulations including plant permit process
Knowledge of EPA Pesticide Registration process
Manufacturing cGMP auditing
Extensive experience as primary customer contact for all product issues related to complaints, claims, and product return
Experience troubleshooting chemical processes for complaint resolution
Experience in all principles of ISO 9001:2015
ISO 9001:2015 internal auditor certification
Working knowledge of FMEA, turtle diagrams, 5 whys, and other Quality tools
Working knowledge of statistical process control
Excellent communication skills
Excellent critical thinking and analytical skills
Ability to read, write, or speak a Chinese dialect is a plus
Multinational company experience in laboratory or operations
Willing to travel to China for extended assignments
Ability to work as part of a team
BS., in Chemistry (required)
MS., a plus
Extensive prior experience working in a chemical production or laboratory (R and D, process, analytical)
Some experience working in Product Safety/Quality Assurance in chemical or pharma manufacturing is a plus
US residents only; no visa sponsorship will be offered
About PHT International, Inc.
PHT International, Inc. (PHT) is a leading Custom Manufacturing Organization for chemicals specializing in the Pharmaceutical, Agricultural and Industrial sectors. Founded in 1993, PHT builds partnerships with leading brands through a commitment to integrity, solving problems and lasting relationships.
Offering research & development, logistics, procurement, QA & regulatory compliance, ownership in plants and joint relationships in strategic geographic areas position PHT as the trusted partner serving a global market.
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The Institute for Operations Research and the Management Sciences
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