Supplier Quality Professiona
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: Quality Specialist
Location: Portsmouth, NH
Hours: Monday - Friday
Employment Type: Long Term Contract (Benefits Available)
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.
Temporary Global Supplier Quality (GSQ) employee will communicating directly and indirectly with suppliers, Client sites, and within their own team, The employee should demonstrate project/time management capabilities in order to monitor the progress of technical documents and assessments. They will work with a team member for guidance, advice, and resolutions that can involve several departments/sites within company. They will be responsible to escalate issues promptly. They employee should maintain awareness that the documents/assessments they produce affect patient safety, drug quality, and client's global reputation.
Key Accountabilities and Duties: Qualifications
Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the minimal aid. Assure issues are timely classified, communicated to the supplier and to Lonza Sites. Promptly notify and escalate to Regional Head Supplier Quality any potential quality or regulatory issues that may affect product quality or regulatory compliance. Participate in the reporting of QA Supplier performance - this is to include Risk Assessment ranking and managing of defined KPI s.
2 year University degree
Preferred area of study: Life Sciences
At least 2 years experience in a regulated industry preferably pharmaceutical or biopharmaceutical.
Knowledge of cGMPs, ISO standards and international regulations. Basic document editing skills
Ability to interpret and relate Quality standards to make sound quality decisions
A working knowledge of the current regulations and the ability to apply that knowledge to assure that providers of materials and services are compliant
Proficient in MS Word applications
Qualities & Attitude:
Strong written and oral communication skills
Strong attention to detail
Effectively interface with people, strong interpersonal skills
Strong negotiation skills
Ability to research
Work independently and dependently; self-driven
Supplier Quality Engineer