Senior Quality Assurance Specialist

Continental Manufacturing; Huxley (IA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Continental Manufacturing in Huxley, IA, is seeking a Sr. Quality Assurance Specialist. This on-site role owns batch record review and product release, ensuring compliance with cGMP and ISO 22716 across pharma, cosmetic, and EPA-regulated lines.

Collaborate with QC, Production, and Regulatory teams to maintain the quality management system. The ideal candidate will lead investigations, manage change controls, and drive CAPA closure with minimal supervision, ensuring on-time product disposition

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology or related field.
• 3+ years of cGMP quality experience in QA/QC/Quality Engineering in pharma/cosmetic/regulated manufacturing.
• Proficiency with FDA cGMP (21 CFR Parts 210 & 211) and ISO 22716.
• Experience leading investigations (deviation, OOS) and CAPA closure.
• Experience with change controls and SOP/documentation management.
• Auditing of internal and supplier systems per schedule.
• Strong documentation and reporting skills; attention to detail.
• Proficiency in MS Office; familiarity with QA systems preferred.

Responsabilités

• Review and approve batch records to confirm SOP/compliance before disposition.
• Lead end-to-end batch record review and resolve discrepancies.
• Lead deviation and CAPA investigations and drive corrective actions.
• Manage change controls and assess regulatory impact before changes.
• Develop and maintain SOPs and quality documentation.
• Plan and conduct internal and supplier quality audits; track corrective actions.
• Support FDA, EPA, and customer audits with readiness activities.
• Prepare quality metrics and support management reviews.

Connaissances

Batch record review

CAPA investigations

FDA cGMP

Change controls

Quality documentation

Audits

Root cause analysis

Cross-functional collaboration

Formation

Bachelor’s degree in Chemistry/ Biology/ Microbiology

Associates degree in Laboratory Technology

Related technical fields degree

Outils

Microsoft Office

Global Shop

SOP management software

Audit support tools

Description du poste

This position is 100% on-site, based in Huxley, IA. Relocation assistance is not available.

Job Title: Sr. Quality Assurance Specialist

FLSA: Exempt

Department: Quality

Reports To: Quality Assurance Manager

The Senior Quality Assurance Specialist owns the batch record review and product release process, exercising independent compliance judgment that directly affects product disposition. As the first role on CMC's QA track, the position requires established quality experience to lead investigations, manage change controls, and maintain the quality management system with minimal supervision. Working across CMC's pharmaceutical, cosmetic, and EPA-registered product lines, the Senior QA Specialist ensures contract manufacturing operations meet FDA cGMP, ISO 22716, and customer requirements. The role embodies CMC's commitment to Character and Commitment — making sound, defensible quality decisions consistently and with integrity — and collaborates closely with QC, Production, and Regulatory partners to keep product moving without compromising compliance.

Essential Duties and Responsibilities

• Review and approve executed batch records, making release determinations that confirm compliance with SOPs, specifications, and cGMP prior to product disposition.


• Manage the batch record review process end-to-end, resolving discrepancies on time and escalating systemic issues.


• Lead deviation, nonconformance, and out-of-specification (OOS) investigations; determine root cause and drive corrective and preventive actions (CAPA) to closure.


• Manage change controls through review and approval, assessing procedural and regulatory impact before implementation.


• Develop, revise, and maintain SOPs, work instructions, and quality documentation in accordance with Good Documentation Practices.


• Plan, schedule, and conduct internal and supplier (external) quality system audits per the audit schedule; document findings and track corrective actions to closure.


• Serve as a subject matter expert in quality systems (21 CFR 210 & 211), drive inspection readiness, and support FDA, EPA, and customer audits and inspections.


• Develop and revise Quality Technical Agreements and assess supplier change notifications to ensure impact is evaluated before implementation.


• Prepare and analyze quality metrics and trending for Management Review; propose and implement corrections for negative trends.


• Provide quality systems and compliance training to staff across the organization.


• Support QC testing, sampling, and floor activities as a cross-training responsibility, providing backup coverage during peak demand or staff absences.


• Interact regularly with leadership, peers, internal customers, and external partners to gain alignment on sound quality decisions.


• Performs other duties as assigned.

Education and/or Experience, Essential Skills and Experience

• Bachelor’s degree in Chemistry, Biology, Microbiology;


• OR Associates degree in Laboratory Technology;


• OR degree in related technical fields


• Three (3) years of cGMP quality experience in a Quality Assurance, Quality Control, or Quality Engineering role within pharmaceutical, cosmetic, or other regulated manufacturing.


• Five (5) or more years of progressive quality experience.


• Training and experience conducting internal and supplier audits.


• Working knowledge of FDA cGMP (21 CFR Parts 210 and 211), ISO 22716, applicable USP test methods, and EPA FIFRA requirements for consumer and antimicrobial products.


• Demonstrated experience with batch record review, deviation and CAPA investigations, and change control.


• Proficiency in product disposition, Good Documentation Practices and SOP management.


• Excellent attention to detail and analytical skills, skilled in root cause analysis and structured problem-solving tools (e.g. 5-Why, fishbone).


• Strong written and verbal communication skills, with an emphasis on clear documentation and reporting.


• Attention to detail, accuracy and timeliness on a consistent basis.


• Ability to work collaboratively in a fast-paced environment and adapt to changing priorities.


• Computer proficiency: Microsoft Office products - Excel, Word, Outlook and Access. Experience with Global Shop is preferred but not required.