Quality Assurance Specialist II

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

Date : Jul 15, 2024

Location : San Diego

Company : Wacker BioTech US Inc.

Are you looking for a new challenge? For our location San Diego we are looking for a(n) Quality Assurance Specialist II .

Job Responsibilities

• Working with the Wacker Biotech US Quality Assurance to ensure compliance with Wacker Biotech US quality expectations and cGMP's.
• Generation and reporting of Quality Metrics, drafting, review and approval of Control document.
• Assisting in supporting the Quality Management System and other Quality duties.
• Supporting record review and product release, internal / external auditing program, processes and manufacturing suites, the training program and investigation activities.
• Ensure compliance of QA controls with the company's best practices and standards.
• Validation experience (Facility, Utilities Equipment or CSV) is a plus.
• Detail oriented and strong communication skills.
• Ability to work in a high pace environment.
• Critical thinking and problem-solving skills.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms, and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.
• Experience in working within document control systems is preferred.
• Experience with Electronic Document and Quality Management Systems preferred.

Job Qualifications

• BA / BS in a scientific discipline with 5+ years' experience in biotechnology or pharmaceutical industry or MS with 4+ years of experience.
• Minimum 4 years' experience in a regulated industry; Quality Assurance role required.
• Other requirements include excellent organizational skills; ability to work independently and in team environments; understanding of FDA / EU GMP / GCP / GLP Quality Requirements;

familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices.

• Through knowledge of GMP, GxP documentation including 21 CFR Part 11 compliance.
• Ability to draft / revise and contribute to SOP and reports.
• Technical review of validation and quality control documents (i.e., Calibration certs, PM, WO).
• Other essential responsibilities as assigned by management.
• Tracking and reporting compliance metrics.

What do we offer?

WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength.

We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.

WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement

We are looking forward to your online application at www.wacker.com.

Reference Code : 27454

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.

A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.

Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).

WACKER is proud to be an Equal Opportunity / Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.

Nearest Major Market : San Diego

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