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Associate Quality Engineer

Catalent Pharma Solutions

Catalent Pharma Solutions

Associate Quality Engineer

San Diego, CA
Full Time
Paid
  • Responsibilities

    CATALENT PHARMA IN SAN DIEGO, CA IS HIRING AN ASSOCIATE QUALITY ENGINEER

    This individual will primarily be responsible for assisting process owners in the investigation of deviations, complaints, and out-of-specification or out-of-trend results (as applicable). This individual will provide technical and regulatory expertise to the deviation management process to ensure patient safety and regulatory compliance. They will work with cross-functional teams to identify root causes and trends, implement lasting corrective actions, and drive continuous improvement in the investigation process. This mid-level position gives opportunities to develop analytical/manufacturing expertise and expand knowledge of overall site-wide operations in a fast-paced, early Phase-focused, dynamic setting to assess the quality of pharmaceutical products under cGMPs and minimal supervision.

    Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

    CATALENT IS COMMITTED TO A PATIENT FIRST CULTURE THROUGH EXCELLENCE IN QUALITY AND COMPLIANCE, AND TO THE SAFETY OF EVERY PATIENT, CONSUMER AND CATALENT EMPLOYEE.

    THE ROLE

    • Leads cross-functional teams to investigate deviations and complaints and provides technical input to the team

    • Interface with internal and external customers

    • Evaluates issues to identify root cause and trends and to ensure they are addressed with the appropriate degree of risk documentation

    • Manages timelines for deviation investigations and complaints to ensure they are addressed in a timely manner

    • Identifies applicable corrective and preventative actions to facilitate deviation and complaint closures.

    • Contributes to the development and improvement of quality processes for deviation and complaint handling, while ensuring site procedures comply with corporate policies and regulatory requirements

    • Understanding of cGMPs, Catalent SOPs and Catalent systems applicable to work performed, and application of ICH and FDA guidance

    • Supports manufacturing with additional responsibilities, such as batch record review and performing line clearances

    • Other duties as assigned

    THE CANDIDATE

    • B.S. degree in a scientific/engineering discipline

    • 2+ years of applicable industry experience (GMP, ISO, or Regulatory), Pharmaceutical GMP experience required

    • Demonstrate exemplary documentation skills for the writing of events, deviations, and investigations

    • Stay current with analytical technology industry standards and equipment

    • Physical: must be able to walk/sit/stand for long periods of time and lift up to 25lbs.

    CATALENT'S STANDARD LEADERSHIP COMPETENCIES:

    • Leads with Integrity and Respect

    • Delivers Results

    • Demonstrates Business Acumen

    • Fosters Collaboration and Teamwork

    • Champions Change

    • Engages and Inspires

    • Coaches and Develops

    WHY YOU SHOULD JOIN CATALENT

    • Potential for career growth within an expanding team

    • Defined career path and annual performance review and feedback process

    • Medical, Dental, Vision and 401k are all offered from Day One of employment

    • 19 days of paid time off (PTO) and 8 paid holidays

    • Awesome employee activities: Movie day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.

    CATALENT OFFERS REWARDING OPPORTUNITIES TO FURTHER YOUR CAREER!

    Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

    Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

    personal initiative. dynamic pace. meaningful work.

    Visit Catalent Careers to explore career opportunities.

    Catalent is an Equal Opportunity Employer, including disability and veterans.

    If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    Notice to Agency and Search Firm Representatives:

    Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    Important Security Notice to U.S. Job Seekers:

    Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

  • Industry
    Pharmaceuticals
  • About Us

    Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.