Sr. QA Systems Specialist

Corden Pharma Colorado

1d

About The Position

Provides support that facilitates seamless execution of the overall objectives of the Quality Department. Supports the administration of Quality Assurance documentation programs, procedures, and controls, ensuring that performance and quality of products conform to established Corden Pharma (CP) standards and federal regulations.

The Sr. QA Systems Specialist plays a key role in ensuring the organization maintains a robust, inspection‑ready Quality Management System (QMS) in alignment with global pharmaceutical and life sciences regulatory expectations. This role oversees regulatory surveillance, corporate standard governance, pharmacopeial compliance, risk assessments, and data integrity initiatives. The specialist partners cross‑functionally to maintain compliance and drive continuous improvement.

Requirements

• Bachelor’s Degree in Science and 8 years of Quality Assurance experience within the Pharmaceutical Industry; or an equivalent combination of education and Pharmaceutical Industry experience.
• Ability to read and comprehend instructions, communications, and the intent of regulatory documentation.
• Ability to write instructions, communications, and general procedures.
• Ability to effectively communicate information in one-on-one and small group situations to Quality Department customers and vendors, regulatory authorities, and other employees of the organization.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, top management, and peers.
• 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 comprehend and carry out instructions furnished in written, oral, or diagram form.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to identify and address interpersonal issues in a professional business manner.
• Ability to work with minimal supervision on complex projects
• Extremely organized and detail oriented. Ability to balance multiple priorities in a dynamic, fast‑paced environment
• Demonstrated ability to collaborate and communicate across all levels of the organization, as well as with customers
• Experience supporting regulatory inspections (FDA, EMA etc.) and customer audits
• Working knowledge of Quality Management Systems and regulatory requirements (e.g. FDA, EMA, ICH, PDMA, USP)
• Experience with electronic QMS platforms (e.g. MasterControl, TrackWise)
• Strong risk management and data integrity knowledge
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills; able to influence cross-functionally

Nice To Haves

• Project management training or certification (PMP, Lean Six Sigma), preferred
• Experience working in a GMP API/DS manufacturing environment, preferred

Responsibilities

• Manages the site level Corporate Compliance Standard implementation process. Maintains compliance with corporate standards by collaborating with SMEs to perform gap assessments and track implementation of updates
• Coordinates site level programs for tracking regulatory and compendial updates. Communicates updates to relevant stakeholders and supports implementation activities
• Maintains customer Quality Assurance Agreements (QAA). Works closely with the customers, project managers, and internal stakeholders to ensure QAAs accurately reflect roles, responsibilities and GMP compliance expectations
• Acts as the site’s subject matter expert for quality risk management procedures and associated software. Develops QRM training and facilitates the performance of cross-functional risk assessments (e.g. FMEA, HACCP, ICH Q9 principles)
• Supports adherence to ALCOA++ and data integrity principles across the QMS. Participates in data integrity assessments, investigations, and remediation initiatives. Develops and delivers training and awareness programs related to data integrity principles.
• Owns and manages quality records to closure due dates including, but not limited, to deviations, change control, and corrective actions, and Preventative Actions (CAPAs)
• Supports regulatory inspections, customer audits and internal audits
• Compiles and communicates departmental metrics, as needed.

Benefits

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level