QA Specialist - Evening Shift

We are seeking a detail-oriented Quality Assurance Specialist to oversee manufacturing documentation compliance, support product development initiatives, and ensure strict adherence to current Good Manufacturing Practices (cGMP). This role involves comprehensive review of production records, analytical data, and quality documentation while collaborating with cross-functional teams to maintain the highest standards of pharmaceutical manufacturing quality.

Responsibilities:

Documentation Review & Compliance

• Conduct thorough audits of batch production records, manufacturing documentation, and analytical testing data
• Review, evaluate, and approve deviation reports and laboratory investigations
• Ensure accurate maintenance and proper documentation of all quality-related records
• Oversee compliance with cGMP regulations across facility operations

Product Quality & Release

• Authorize release of in-process materials for continued manufacturing and finished products for distribution
• Execute cleaning verification procedures including visual inspections and swab testing
• Support product disposition decisions based on quality assessments
• Review and approve critical quality documents including SOPs, protocols, and analytical methods

Cross-Functional Collaboration

• Provide quality assurance expertise for product development and contract manufacturing projects
• Collaborate with customer quality teams and external partners as needed
• Partner with all internal departments to ensure quality objectives are met
• Contribute to company, departmental, and individual goals as established by leadership

Professional Standards

• Maintain strict confidentiality of proprietary and sensitive information
• Demonstrate consistent attendance and reliability
• Execute all tasks safely with continuous attention to detail
• Uphold company policies including professional conduct, anti-harassment, and business ethics standards
• Work effectively in deadline-driven environments while maintaining quality standards

Required Qualifications:

Education & Experience

• Bachelor's degree required
• 2-6 years of quality assurance experience in pharmaceutical or similarly regulated industries

Technical Skills

• Proficiency with Quality Management Systems (Veeva experience preferred)
• Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint)
• Strong understanding of cGMP requirements for documentation and records management in bulk pharmaceutical and solid oral dosage manufacturing

Specialized Knowledge (Preferred)

• Experience with large-scale processing systems, fluid air systems, or coacervation systems
• Practical knowledge of pharmaceutical manufacturing processes and quality control procedures

Core Competencies

• Exceptional attention to detail and accuracy in document compilation
• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Ability to work collaboratively in team environments
• Commitment to maintaining high-quality standards under pressure

If you meet the required qualifications and are interested in this role, please apply today.

Clinical Resource Network Distinction

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.

About CRN

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.

Opportunity Awaits.

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