Quality Control Analyst III

Curia Aalborg ApS; Camarillo (CA); On-site; USD 85,000 - 107,000; Full time

Benefits offered by this job

Generous benefits

Paid training

Career advancement

Education reimbursement

401K with matching

Learning platform

And more!

Job summary

Curia in Camarillo, CA is seeking a Quality Control Analyst III to support the manufacturing department and external customers. The role includes testing raw materials, in-process, end product, and stability samples, with emphasis on data evaluation and method validation.

Applicants should have a chemistry degree with significant related experience, familiarity with FDA GMP guidelines, and the ability to work flexible hours.

Qualifications

• Bachelor's degree or higher in Chemistry or related field with relevant experience.
• Experience in cGMP or GLP pharmaceutical environments is preferred.
• Ability to work nights/weekends as needed.

Responsibilities

• Perform complex testing and data evaluation (e.g., HPLC, ELISA).
• Troubleshoot equipment issues and communicate resolutions.
• Lead/participate in method validations and data trend evaluations.
• Support OOS investigations with root-cause analysis and CAPAs.
• Prepare SOPs, reports, and data summaries for management.

Skills

Verbal & written communication

Time management

Organizational skills

Problem solving

Team collaboration

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry

PhD in Chemistry

Tools

Microsoft Office

Instrument systems knowledge

Job description

Quality Control Analyst III in Camarillo, CA

Build your future at Curia, where our work has the power to save lives.

The Quality Control Analyst III is responsible for supporting the manufacturing department and external customers. Routine functions include testing of raw materials, in-process, end product, and stability samples.

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. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• 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!

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

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 (nights and weekends), as-needed (overtime eligible)

Knowledge, skills and abilities

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

Other Qualifications

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

May be required to obtain and maintain gowning certification

May be required to obtain and maintain media qualification

Pay Range: $85,000-$106,500/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

Curia is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Curia is an E-Verify employer.