Senior QA Specialist - GMP

Senior QA Specialist - GMP

 

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.

 

The Opportunity:

The Senior QA Specialist, GMP will perform activities related to Quality Assurance for the manufacture and release of clinical phase products. The candidate will support all QA activities for oversight of manufacturing, compliance, auditing, and release of product at external manufacturing CMOs. Responsibilities include review of batch production records, method validations, change control, CAPA, deviations and investigations, and maintenance of compliance logs. They will interact with internal cross‑functional groups including Technical Operations, Regulatory Affairs, and Clinical Operations, as well as Contract Manufacturing Organizations and Analytical Laboratories.

 

What You Will Dive Into:

 

• Review, approval, and release of manufacturing and labeling batch records and product

Review and approval of specifications, method validations

 

• Initiation and Review of internal and external compliance documents such as change control, deviations, investigations, and CAPA

 

• Maintenance of QA compliance logs

 

• Use of an Electronic Data Management System for review, approval, and archiving of documents

 

• Manage and maintain relationships and communication within internal teams and Contract Manufacturing Organizations

 

• Author and review of Standard Operation Procedures

 

• Assist with internal and external audits, as needed

 

What We Expect:

 

• BA/BS in Biology or related Science preferred, or equivalent experience

 

• 4-7 years of experience in Pharmaceutical and/or Biotech related fields, knowledge of cGMP

 

• 1-3 years of experience within Quality Systems

 

• Strong background in Drug Substance and/or Drug Product Manufacturing, knowledge of European regulations is a plus

 

• Strong organizational, interpersonal and communication skills, and excellent written communication skills

 

• Able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams

 

• Some travel required

 

What We Offer:

 

• To be part of a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives

 

• Opportunities to learn and contribute to creative solutions

 

• Competitive compensation package including long-term incentives

 

• Comprehensive health insurance (highly subsidized cost sharing on all medical plans)

 

• Generous matching 401k retirement plan

 

• Flexible time off policy and holidays including two company-wide shut-down periods each year

 

• Multi-cultural work environment

 

• Company celebrations

 

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.

 

To apply, visit: https://apptrkr.com/2336383