Quality Assurance Specialist 2

Quality Assurance Specialist II in Springfield, MO

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

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! 

The Quality Assurance Specialist II serves as a quality partner to manufacturing and laboratory operations, providing on-the-floor oversight, data and documentation review, and proactive compliance support. This role identifies and addresses compliance risks, supports resolution of quality events, and helps ensure manufacturing and laboratory activities are performed in accordance with cGMPs, data integrity principles, and Curia procedures.

The QA Specialist II supports Curia’s Quality Management System through analytical data review, quality event management, audit support, and maintenance of quality systems and records while collaborating across functions to promote consistent, compliant execution.

Essential Responsibilities

Floor Presence and Compliance

• Provide on-the-floor QA oversight to manufacturing operations, proactively identifying compliance risks and supporting day-to-day quality activities.

• Represent Quality Assurance when issues require immediate corrective action, ensuring actions are appropriate, compliant, and accurately documented.

• Support the initiation, documentation, investigation, and resolution of deviations and other quality events.

• Monitor operations for compliance with approved procedures, batch records, protocols, cGMP requirements, and Good Documentation Practices.

• Partner with Manufacturing, Quality Control, Technical Services, and other functions to resolve quality issues, support real-time compliance, and escalate significant concerns to Quality Management.

• Provide guidance to personnel regarding cGMP requirements, site procedures, documentation practices, and quality expectations.

Data and Documentation Review

• Review Quality Control analytical testing and associated data for completeness, accuracy, traceability, and compliance with approved methods, specifications, SOPs, cGMP requirements, and data integrity principles.

• Review analytical documentation, including chromatography and other laboratory-generated data, as applicable, to verify appropriate execution, calculations, results, and adherence to established procedures and specifications.

• Identify discrepancies, atypical results, documentation errors, and potential data integrity concerns and partner with laboratory personnel and Quality Management to ensure appropriate evaluation and resolution.

• Review manufacturing and quality documentation, including batch records, protocols, controlled forms, and other cGMP records, for completeness and compliance.

• Apply sound judgment and critical thinking when reviewing data and documentation and ensure corrections or clarifications are completed in accordance with Good Documentation Practices.

Quality Systems

• Author, review, and/or approve Quality Management System documentation, including SOPs, deviations, change controls, CAPAs, controlled forms, and other quality records within assigned authority.

• Support investigations through documentation and data review, information gathering, and evaluation of immediate actions.

• Maintain Quality databases, electronic systems, training records, controlled documents, archives, and other cGMP records as assigned.

• Assist with Quality System metrics and other information used for management review.

• Participate in internal audits, client audits, regulatory inspections, and other quality assessments, including gathering and reviewing supporting documentation and completing assigned follow-up actions.

• With appropriate guidance, support responses to clients regarding manufacturing, testing, documentation, and quality-related issues.

• Support QA visual inspection activities as required.

Training and Continuous Improvement

• Maintain required training and provide guidance or training to personnel on cGMP requirements, Good Documentation Practices, site procedures, and other quality requirements within areas of expertise.

• Identify opportunities to strengthen compliance, data integrity, documentation practices, and Quality System effectiveness.

• Collaborate across departments to promote a culture of quality, accountability, continuous improvement, and proactive problem solving.

Good Manufacturing & Documentation Practices

Quality is something we take pride in together. You’ll perform your work in alignment with cGMP requirements and Curia’s standards to ensure our facilities support the safe and reliable manufacture of products for our customers.

• Perform all documentation in compliance with ALCOA++ principles and site SOPs.

• Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.

• Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

• Apply data integrity principles when reviewing electronic and paper records, including source data, metadata, audit trails, and associated documentation, as applicable.

Qualifications

Required

• Bachelor’s degree in Life Science, Chemistry, Biology, or a related scientific discipline; relevant education and experience may be considered in lieu of a degree.

• 3–6 years of Quality Assurance, Quality Control, laboratory, manufacturing, or related experience within a pharmaceutical, biotechnology, medical device, or other FDA-regulated cGMP environment.

• Experience reviewing cGMP documentation and/or analytical laboratory data for completeness, accuracy, compliance, and adherence to approved procedures and specifications.

• Working knowledge of FDA regulations, cGMP requirements, Good Documentation Practices, and data integrity principles, including ALCOA+.

• Ability to identify and evaluate documentation, data integrity, quality, and compliance concerns and appropriately escalate issues when needed.

• Strong critical-thinking, problem-solving, organizational, and attention-to-detail skills with the ability to manage multiple priorities in a fast-paced cGMP environment.

• Effective written and verbal communication skills with the ability to work independently and collaboratively across functions.

• Proficiency with Microsoft Office and the ability to learn applicable electronic Quality, laboratory, documentation, and data management systems.

Preferred

• Experience reviewing analytical laboratory and chromatographic data, including HPLC, GC, or other analytical instrumentation and associated data systems.

• Familiarity with 21 CFR Parts 210 and 211 and applicable ICH guidance, including ICH Q7, Q9, and Q10.

• Experience supporting deviations, investigations, CAPAs, change controls, audits, or regulatory inspections.

• Experience working in a pharmaceutical API manufacturing environment.

Other Qualifications

•    Must pass a background check
•    Must pass a drug screen
•    May be required to pass Occupational Health Screening
 

PHYSICAL REQUIREMENTS

The physical demands described below are representative of those required to successfully perform the essential functions of this role.

• Regularly required to sit, stand, walk, talk, and hear.

• Frequently required to use hands to handle or feel objects, reach with hands and arms, and climb, balance, stoop, kneel, crouch, or crawl.

• May occasionally lift and/or move up to 55 pounds.

• Visual requirements include close vision, distance vision, peripheral vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described below are representative of those encountered while performing the essential functions of this role.

• Regular work in a standard office environment, with frequent entry into the production area of a pharmaceutical manufacturing facility.

• Production environment may include moving mechanical parts, fumes or airborne particles, extreme heat, wet or humid conditions, low levels of toxic or caustic chemicals, and outdoor weather conditions.

• Noise level in the work environment is typically moderate.
   

This job description reflects the general nature and scope of the role and is not exhaustive.We’re a growing organization, and opportunities to contribute beyond this list are part of what makes Curia exciting. We’re committed to reviewing reasonable accommodation requests to enable individuals with disabilities to perform the essential functions of this role

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.