Quality Control Analyst I, II or III

The Quality Control Analyst I, II, or 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. This role may be filled as a Quality Control Analyst I, II, or III depending on level of education and experience.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a Salary Non-Exempt Role (eligible for payment of overtime in accordance with Fair Labor Standards Act).

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
• Paid training, vacation, and holidays
• Career advancement opportunities
• Education reimbursement
• 401k program
• And more!

Essential Job Duties

• Perform complex testing and data evaluation such as TGA
• Perform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
• Participate in or assist with test method validations
• Evaluate data for trends
• Support supervisors in OOS Investigations and complete CAPA requirements
• 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 on paperwork
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries
• Understand and use basic risk assessment and root cause tools
• Train upon and understand methods, equipment, and standard operating procedures
• 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
• Perform tracking and trending of data as requested
• Compile data and provide data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Interact with other departments within the company for testing needs and scheduling
• May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
• May lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability results
• Good Manufacturing Practices & Good Documentation Practices (GMP & GDP)
• Perform all GMP related documentation in compliance with ALCOA and good documentation practices as defined by site SOP's
• Strict compliance with all cGMP documents SOP's, Batch records, protocols, change controls, controlled forms, etc.
• Ensure all cGMP applicable training is kept current
• Do not perform any cGMP task for which have not received appropriate training
• Escalate any cGMP concerns to Supervisors and to Quality Department as needed
• Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices.

Education, Experience, Certification, and Licensures

• Required: Bachelors degree in Chemistry or related field
• QC Analyst I: 0-2 Years Experience
• QC Analyst II: 3-5 Years Experience
• QC Analyst III: 5-7 Years Experience
• Preferred: Experience working in cGMP or GLP pharmaceutical industry environment

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 procedure manuals
• 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 deal with 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

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is regularly required to talk or hear.
• The employee is frequently required to stand; walk; or sit; use hands to finger, handle, or feel and reach with hands and arms.
• The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals.
• The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation, and vibration.
• The noise level in the work environment is usually moderate.

Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

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. #LI-DR1