Sr Quality Assurance Associate

Job Description

Job Description

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

MISSION

Under supervision of QA management, the Sr. Associate, Quality Assurance will support documents review, the company SOPs and training management, and market distribution of batches.

RESPONSIBILITIES

• Support management of the SOP system, including writing/revising and maintaining SOPs, SOP Tracking and SOP Training
• Participate in the review and internal tracking of manufacturers’ change controls
• Support product quality complaints system including classification of complaints, complaint response letters issuance and notification to manufacturers
• Participate in the QA review and internal product launch process for ANDA drug product, OTC, Dietary Supplement and Medical Food products
• Support the QA management in quality investigations relating to quality-related complaints, as required
• Product Quality Reviews, including review of manufacturers’ reports of annual product reviews, as required
• Market distribution process
• Conduct batch record reviews, as required

JOB REQUIREMENTS

Education:

• BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)

Experience:

• Minimum 5 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems

Experience

Required:

• Knowledge of quality and compliance for drug production.
• Knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)
• Attention to detail and organizational skills

• Strong written and verbal communication skills
• Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Excel, Outlook

At Breckenridge Pharmaceutical Inc, we take pride in being an equal opportunity employer. We are committed to creating an inclusive workplace and do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other characteristic protected by law. Employment decisions are made based on individual qualifications, merit, and the needs of the business.

Beyond the base salary, Breckenridge Pharmaceutical Inc. provides a comprehensive and competitive total rewards package. This may include annual bonuses, health benefits such as medical, dental, and vision insurance, life insurance, a 401(k) plan with company matching and favorable vesting terms, paid holidays and vacation.