Senior QA Associate

Corden Pharma - A Full-Service CDMO

Quality Assurance Associate responsible for administering QA programs and ensuring compliance in pharmaceutical manufacturing. Collaborating with teams to address quality issues and regulatory requirements.

Posted 5/9/2026full-timeBoulder • Colorado • 🇺🇸 United StatesSenior💰 $89,000 - $111,000 per yearWebsite

About the role

Key responsibilities & impact

Administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations.
Works directly with manufacturing and support groups to address quality issues with cGMP activities.
Participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility.
Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs.
Acting as the QA Representative on project teams as needed.
Is the QA Generalist and resource on cGMP issues, who understands cGMP, Data Integrity, and GDP requirements and expectations.
Participates in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records.
Reviews completed/executed batch records in support of lot release.
Compiles supporting data/information for lot release.
Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API.
Reviews and approves stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval.
Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain).
Serves as overall back up to other Quality personnel as appropriate.

Requirements

What you’ll need

Knowledge of cGMPs, GDPs, and Corden Quality SOPs, and guidelines as they apply to documentation protocol and validation activities
Knowledge of process protocols, batch record requirements, and deviation reporting adequacy
Ability to apply attention to detail and regulatory requirements; and a practical, defendable, and logical approach to problem solving
Bachelor's Degree (BA) from 4-year college or university; or 2 years Pharmaceutical Manufacturing experience in a technical support or production role; or equivalent combination of education and experience.
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 effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to speak, read, and write in English.

Benefits

Comp & perks

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 Paternal Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

cGMPGDPvalidationqualificationchange controlbatch recordsstability reportsSOPdocumentation protocoldeviation reporting

Soft Skills

attention to detailproblem solvingcommunicationanalytical skillsreport writingpresentation skills