QUALITY MANAGER
American Cybersystems, Inc.

Job Info

Innova Solutions is immediately hiring for an QUALITY MANAGER

Tittle - 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, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws