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QC Reference Standard Specialist

Company: Cambrex
Location: Charles City
Posted on: September 24, 2022

Job Description:

Overview Reporting to Quality Control Manager, the Reference Standard Specialist will author reference standard protocols, execute reference standard protocols (data collection), and generate reports and certificates of analysis for site and client approval. Responsibilities - Track reference standards requiring qualification relative to the production schedule and monitor reference standard inventories. - Generate qualification and requalification protocols. - Execute testing such as HPLC, GC, etc. to qualify materials as reference standards in a timely and efficient manner. - Author qualification reports and certificates of analysis upon the completion of reference standard testing. - Review qualification data as needed. - Work with clients/project managers to ensure that client provided certificates of analysis are provided in a timely manner to support testing of production samples. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications - BS in Chemistry or a related field. - cGMP knowledge required - Minimum 3 or more years of experience within quality control. - Proficiency in a windows-based environment including word processing, spreadsheet and database programs Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Relocation assistance will be offered for this position.

Keywords: Cambrex, Rochester , QC Reference Standard Specialist, Other , Charles City, Minnesota

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