Job summary
Job post source
This job is directly from Appco Pharma LLC
Job overview
The Manager, Quality Assurance at Appco Pharma LLC oversees pharmaceutical batch record review and ensures compliance with quality standards to maintain product integrity.
Responsibilities and impact
The role involves reviewing and approving batch records, certificates of compliance, analytical methods, overseeing quality management systems, managing change controls, deviations, CAPA, OOS, and ensuring calibration compliance and guideline development for cGMP and SOPs.
Experience and skills
Requires a Master's degree in Chemistry, Pharmaceutics, or related field with knowledge in raw material analysis, sample validation, internal audits, SOP implementation, equipment calibration, and batch record drafting.
Job location and travel
Position is located in Piscataway, NJ at Appco Pharma LLC headquarters.
Application process
Applicants should send their resume to APPCO Pharma LLC, 262 Old New Brunswick Rd., Suite N, Piscataway, NJ 08854.
Company overview
Appco Pharma LLC is a pharmaceutical company specializing in the development, manufacturing, and distribution of generic medications. They generate revenue by producing cost-effective generic drugs that provide affordable alternatives to brand-name medications, catering to a wide range of therapeutic areas. Established with a commitment to quality and innovation, Appco Pharma focuses on maintaining high standards in its manufacturing processes and regulatory compliance. The company is known for its robust research and development efforts, aiming to expand its product portfolio and market presence. Candidates should be aware of Appco Pharma's emphasis on quality control and its strategic initiatives to enhance its position in the competitive pharmaceutical industry.
How to land this job
Position your resume to highlight your expertise in reviewing and approving pharmaceutical batch records, emphasizing your familiarity with cGMP and SOP development as outlined in the job description.
Stress your experience managing quality systems including QMS, change controls, CAPA, deviations, and OOS investigations, ensuring regulatory compliance and operational excellence.
Apply through Appco Pharma LLC’s corporate career site, LinkedIn, and other pharmaceutical job boards to maximize your application visibility.
Connect with current employees in the Quality Assurance division at Appco Pharma LLC on LinkedIn; use ice breakers like commenting on recent regulatory updates in pharma or asking about their approach to CAPA management to start conversations.
Optimize your resume for ATS by incorporating keywords such as 'batch record review,' 'certificate of compliance,' 'analytical method validation,' 'QMS,' 'cGMP,' and 'SOP implementation' to pass initial screenings effectively.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, multi-channel submissions, and targeted networking, allowing you to focus your time on preparing for interviews and skill development.
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