Quality Control Analyst III jobs in United States
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Curia · 1 month ago

Quality Control Analyst III

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. The Quality Control Analyst III is responsible for supporting the manufacturing department and external customers through testing of raw materials, in-process, end product, and stability samples.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Perform complex testing and data evaluation, such as HPLC, ELISA, etc
Troubleshoot equipment issues promptly and communicate resolutions to management
Participate in or assist with test method validations
Evaluate data for trends
Support and/or investigate OOS events by performing thorough root cause analyses, assessing potential product impact, and implementing appropriate CAPAs
Interact with outside departments including attending meetings, providing updates, etc
Coordinate testing performed at outside testing labs, raw materials, etc
Maintain a detailed and accurate recording of activities and results
Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries
Perform risk assessment as needed
Write/revise test methods, standard operating procedures, etc
Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
Support equipment upkeep
Prepare and order supplies, as necessary
Enter data into relevant data management systems and perform tracking and trending of data. Compile data and provide/present data summaries to management
Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
Collaborate with cross-functional departments to coordinate testing, scheduling needs, and prioritization
Lead departmental projects and participate in cross-functional teams, including continuous improvement initiatives and new customer project teams
Lead the stability program, including management of test points, reporting of data, and investigations of out of specification or aberrant stability results

Qualification

HPLCELISACGMPGLPFDA GMPsMathematical conceptsData analysisMicrosoft Office SuiteCommunicationTime managementOrganizational skills

Required

Bachelor's Degree in Chemistry or related field and 5+ years related work experience
OR
Master's Degree in Chemistry or related field and 3+ years related work experience
OR
PhD in Chemistry or related field and 1+ years related work experience
Experience working in cGMP or GLP pharmaceutical industry environment
Willing to work flexible hours, as-needed
Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to meet deadlines and work under pressure with limited supervision
Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedures
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and handle several abstract and concrete variables
Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems
Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase