Quality Control Analyst III

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.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. 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.