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Innova Solutions is immediately hiring for an QUALITY MANAGERTittle - QUALITY MANAGER Duration -12 Months Location - New Brunswick, NJ (onsite) Pay Range: $45.23- $46.20 per hour. As a(n) QUALITY MANAGER you will: Job Description: Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all and applicable Food and Drug Administration (FDA) and international regulatory standards. Responsibility to ensure that released products comply with internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls). Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed Determines disposition of drug products according and regulatory specifications and standards Review change requests generated internally or by External Manufacturer Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action Review Quality Agreements Review and approve product quality complaint investigations Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements Write, review and implement SOP's to ensure compliance with current standard and current Good Manufacturing Practices (cGMP) Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM) Supports product recalls and executes plan as assigned Represent during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements Assist with preparation of audit observations Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate and FDA and European Medicines Agency (EMA) cGMP regulations and policies Represent Quality on cross-functional teams within the \"Virtual Manufacturing Plant\", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams The ideal candidate will have: B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent Minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience Experience in a Quality Assurance, Quality Control or equivalent function is required Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired Knowledge in solid dosage forms, parenteral technology, biologics or combination products Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA). Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Aritra Roy 4702230481 Aritra.Roy@innovasolutions.com PAY RANGE AND BENEFITS: Pay Range: $45.23- $46.20 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, anTo view the full job description, click here