Talent.com
Tarsanet
Manager II, Quality Assurance (Commercial)Tarsanet • Irvine, CA, United States
No longer accepting applications
Manager II, Quality Assurance (Commercial)

Manager II, Quality Assurance (Commercial)

Tarsanet • Irvine, CA, United States
30+ days ago
Salary
$120,000.00 yearly
Job type
  • Full-time
Job description

Manager II, Quality Assurance (Commercial)

Irvine, California, United States

Reporting to the Associate Director, Quality Assurance, the Manager II, Quality Assurance, is responsible for the review and processing of manufacturing Deviations and Laboratory OOS, and review of manufacturing-related Change Controls within Tarsus' established QMS system. This role will also be responsible for authoring Annual Product Reviews, analyzing and trending analytical data, approval of Certificates of Analysis, manufacturing batch record review and product disposition.

Let's talk about some of the key responsibilities of the role:

  • Review/Approve Vendor Change Controls
  • Review/Approve vendor documents including Master Batch Records/Master Packaging Records
  • Review Specifications
  • Review/Approve Deviations/OOS
  • Analyze and trend data
  • Author Annual Product Reviews
  • Author/Revise relevant Quality Assurance Procedures
  • Review new proposed master manufacturing records and manufacturing-related process validation protocols
  • Review/Approve Test Record Review Form and Certificate of Analysis
  • Review/Approve executed manufacturing batch records and packaging batch records
  • Review/Approve/Complete Batch Record Review Form (Batch Disposition)
  • Complete Final Product Disposition Form and Certificate of Compliance
  • Participate in internal Operations
  • Participate in Meetings/discussions with Tarsus' manufacturing partners and testing laboratories

Factors for Success:

  • Bachelor's Degree preferred, plus 8+ years' experience in the Pharmaceutical Industry
  • 5+ years experience in Pharmaceutical Quality Assurance
  • Strong attention to detail
  • Proficient technical skills across multiple platforms
  • Strong knowledge of Microsoft Office Systems
  • ASQ Certification Preferred

A Few Other Details Worth Mentioning:

  • The position is hybrid and will be based in our beautiful Irvine office three days per week, complete with a courtyard, snacks, drinks, occasional catered meals, and pet-days.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days.

Create a job alert for this search

Manager II, Quality Assurance (Commercial) • Irvine, CA, United States

Similar jobs

Supervisor, Quality Assurance

AbbottPomona, CA, United States
Full-time

Job Title: Supervisor, Quality Assurance.At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.Career development with... Show more

 • Promoted

Mission Assurance Manager

Terran OrbitalIrvine, CA, United States
Full-time +1

Join a team where your impact reaches beyond the stars! At Terran Orbital, you're not just part of the system you're a vital force propelling our mission forward.As trailblazers in satellite manuf... Show more

 • Promoted

Quality Manager

AmeriPharmaLaguna Hills, CA, United States
Full-time

The Quality Manager is responsible for managing, maintaining, and continuously improving the organization's Quality Management Program.This role oversees quality assurance activities, process revie... Show more

 • Promoted

QA/QC Manager

StaffosaurusIrvine, CA, United States
Full-time

About Us We are a licensed and accredited full-service medical reference laboratory with an extensive test menu of specialty assays.Our vision is to deliver information to our clinicians with accur... Show more

 • Promoted

Quality Assurance Manager

Ellwood National ForgeIrvine, CA, United States
Full-time

ENF is currently seeking a Quality Assurance Manager (QA Manager) to join our team.Responsible for ensuring that all processes and systems meet the highest standards of quality and compliance, this... Show more

 • Promoted

Quality Assurance Manager

Reyes Coca-Cola BottlingRancho Cucamonga, CA, United States
Full-time

Join the leading beverage provider, Reyes Coca-Cola Bottling! Shift: Full Time, open to all shifts Benefits: Medical, Dental, Vision, 401K Match, PTO, Education Reimbursement Salary: $105,840-$132,... Show more

 • Promoted

Assurance Manager - Industrial Goods

RSMIrvine, CA, United States
Full-time

Manager, Industrial Products Assurance Team.RSM is looking for a Manager to join our Industrial Products assurance team.You will have the opportunity to work as a team member on diverse client enga... Show more

 • Promoted

Manager-Business assurance & compliance EHS

Hyundai GlovisIrvine, CA, United States
Full-time

Manager Business Assurance & Compliance.Since 2002, we have delivered innovative transportation and supply chain solutions across the U.We support the automotive, freight forwarding, parts distrib... Show more

 • Promoted

Corporate Quality Assurance Manager

Prudential Overall SupplyIrvine, CA, United States
Full-time

Prudential Overall Supply is seeking an experienced Quality Assurance Manager to lead and advance our enterprise Quality Management System (QMS) across all facilities nationwide.This role plays a c... Show more

 • Promoted

QUALITY MANAGER

ADDMANIrvine, CA, United States
Permanent

The Quality Manager at ADDMAN Precision Minneapolis will work to apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual pr... Show more

 • Promoted

Manager, Battery Cell Safety

RivianTustin, CA, United States
Full-time +1

About Rivian Rivian is on a mission to keep the world adventurous forever.This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract... Show more

 • Promoted

Senior Manager, Quality Control

GileadLa Verne, CA, United States
Full-time

Senior Manager, Quality Control.At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working ... Show more

 • Promoted

FAA Quality Assurance Manager

CIRCOR InternationalEastvale, CA, United States
Full-time

CIRCOR Aerospace & Defense is focused on the design, development, and manufacture of specialty fluid and motion control products for demanding aerospace and defense applications.CIRCOR products are... Show more

 • Promoted

Regional Quality Manager

GHDIrvine, CA, United States
Full-time

At GHD, we don't just believe in the power of commitment, we live and breathe it every day! That's why we pledge to support and empower all our people to make a positive impact when working hand in... Show more

 • Promoted

Quality Manager, Overwatch | Irvine, CA

Blizzard EntertainmentIrvine, CA, United States
Full-time +1

Quality Manager, Overwatch | Irvine, CA.YOUR MISSION AND ABOUT BLIZZARD QUALITY ASSURANCE (QA) At Blizzard Entertainment, we pour our hearts and souls into everything we create.Best known for iconi... Show more

 • Promoted

Leader Software Quality V&V CSV/CSA

STAAR SurgicalFoothill Ranch, CA, United States
Full-time

Director Of Software Validation.The Director of Software Validation is responsible for leading STAAR Surgical's software validation organization and for software quality oversight across Informatio... Show more

 • Promoted

Director, Quality Systems

MasimoIrvine, CA, United States
Full-time

The Director, Quality Systems is responsible for leading and advancing the company's Quality Systems strategy, governance, and operational effectiveness to ensure ongoing compliance with global reg... Show more

 • Promoted

Quality Assurance Manager

KMR Search GroupIrvine, CA, United States
Full-time

Job Description Summary: The Manager of Quality Assurance is responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system which sup... Show more

 • Promoted

Director, Quality (Clinical Laboratory)

Quest DiagnosticsTrabuco Canyon, CA, United States
Full-time +1

Pay range: $175,000-210,000, plus yearly bonus.Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications o... Show more

 • Promoted

Sr. Manager, Design Assurance Engineering

EnvistaPomona, CA, United States
Full-time

Manager, Design Assurance Engineering.Manager, Design Assurance Engineering is a strategic leader responsible for driving product quality, regulatory compliance, and innovation across the full prod... Show more