Wedgewood Pharmacy
Pharma
QualityManager
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optimal for Manager candidates.
“Quality Manager at Wedgewood Pharmacy. Skills: Quality assurance, Quality control, CGMP compliance, Regulatory inspections. Prepare/review/approve controlled documents. Review/approve change controls”
What You'll Achieve.
High-quality execution; Maintaining accuracy; Meeting stakeholder needs; Meeting regulator needs
Industry & Context.
OOS investigations
What They're Looking For.
Must Have
Bachelor's Degree, 10+ years experience biotechiopharma/medical device/pharma, 7+ years quality experience, 7+ years managing staff, Held quality role batch disposition, Vast experience 21CFR Part 11 QMS, Experienced interfacing regulatory agencies, Prior experience QMS systems implementation, Prior experience auditing API brokers/manufacturers, Prior experience auditing contract manufacturing organizations, Prior experience auditing contract testing laboratories, Sterility experience
Nice to Have
CGMP, USP 795, USP 797, State Board of Pharmacy regulations, Section 503B of Federal FD&C Act
What You'll Do.
Prepare/review/approve controlled documents
Review/approve change controls
Review/approve executed validation documents
Assist leading regulatory inspections
Create annual product reviews
Review/approve product label changes
Oversee communication external laboratories
Oversee quality incoming materials
Oversee sample reserve program
Support Vendor Management program
Ensure direct reports allocated
Participate cross functional teams
Provide quarterly metrics/trends
Stay current applicable laws/regulations
Contribute development quality systems/procedures
Oversee Sterility Assurance
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal audits; External audits
Full Job Description
At Wedgewood Pharmacy, we are dedicated to improving the lives of animals through customized medication and compassionate care. Every role in our organization contributes to helping pets live healthier, happier lives. We are a team driven by purpose, quality, and a shared commitment to animal health. We are seeking a Quality Manager to join our team. In this role, you will help support our mission by ensuring high-quality execution of daily responsibilities, maintaining accuracy, and contributing to a collaborative environment focused on patient care and continuous improvement. The Quality Manager is responsible for managing quality assurance and quality control processes and teams at the Albany 503b manufacturing facility. This includes oversight of all quality assurance and all quality control functions. This individual will participate in supporting and independently work through quality processes that reinforce the company’s values of customer focus, integrity, collaboration, and innovation while meeting the needs of our stakeholders and regulators. The Quality Manager leads and manages direct reports and ensures their activities occur in accordance with cGMP, USP 795, USP 797, State Board of Pharmacy regulations, Section 503B of Federal FD&C Act and company policies and procedures. The Basics Location: Albany, OH, Onsite Job Type: Full Time Schedule: Mon- Fri Compensation: The base pay range for this position starts at $110K base plus an annual bonus commensurate with the individual's experience and qualifications. Benefits: Eligible How You Will Make an Impact Prepare and/or review/approve controlled documents (e. g. SOP’s Batch Records, Specifications, Protocols, Deviation reports, OOS investigations) Review and approve change controls ensuring adequate justification, impact assessment and implementation plan. Review and approve executed validation documents ensuring specifications were met. Assist in leading all regulatory inspections of the site, including
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