Quality Assurance Compliance Supervisor, Pharmaceutical Manufacturing

Description

Padagis is hiring a Quality Assurance (QA) Supervisor to ensure the quality and compliance of operational activities occurring at the facility by overseeing the following programs; validation, internal auditing, data review, product complaints, product lifecycle, change management, investigations, CAPA and continuous improvement. The person selected for this position will supervise 5-10 QA engineers.

This position pays $75,000 - $100,000 USD annually in addition to two incentive bonus plans and a robust and affordable employee benefits program.

Minimum qualifications :

• Bachelor's Degree in engineering, a science discipline, or closely aligned field.
• 5+ years experience in a cGMP manufacturing environment and one to two years of previous supervisory experience
• Demonstrated experience applying cGMP's and US FDA laws and requirements in an FDA regulated industry
• Excellent oral and written communication, interpersonal skills, and computer literacy, including Microsoft Excel and Word.
• Strong attention to detail and ability to follow written procedures.
• Demonstrated ability to make quality decisions when upset conditions arise.
• Knowledge and experience in validation concepts (process, method, computer and cleaning), equipment qualification, change management, product lifecycle, master record approval, internal auditing, data review, risk mitigation, investigations and CAPA planning.

Preferred qualifications :

Job duties :

Major Duties / Responsibilities

% of Time

1. Provides support and oversight of site activities related to quality

50%

2. Participates in quality events and closes unplanned deviation events

20%

3. Conducts training for direct reports and takes part in needed training to perform job function.

10%

4. Provides performance-based feedback to direct reports, including completion of annual performance reviews.

5%

5. Seeks assistance on Human Resource issues.

5%

6. Participates in Continuous Improvement initiatives.

10%

Padagis Core Competencies :

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five "core" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies :

About Us :

At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

What's Next :

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

Qualifications

Education

Bachelors of Chemistry (preferred)

Bachelors of Microbiology (preferred)

Bachelors of Engineering (preferred)

Experience

1 years : Supervisor (required)

1 years : Quality Assurance (preferred)

5 years : cGMP manufacturing environment (required)

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.