Stability Coordinator

Stability Coordinator

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Quality Assurance Department maintains oversight of laboratory operations to ensure activities are performed in a compliant manner. This includes oversight of computer systems, stability program, data auditing as well as support for laboratory investigations and technical reviews.

Position Summary

The Stability Coordinator is responsible for generating stability protocols, initiating stability storage, Supports the review of Quality agreements and ensures stability program requirements as directed in the QAA are met as necessary. Secondary support to the Associate Stability Coordinator when required to identify and retrieve samples as required per the stability schedule and documents the receipt of samples for analysis into the laboratory. Ensures all related documents are fully and accurately completed in accordance with SOP, and ICH guidelines. Comply with divisional and site Environmental Health and Safety requirements.

Monday- Friday Day Shift

The Role

• Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Company's Quality Policies. Complies with local and global policies and procedures to oversee and maintain the site stability program
• Ensures compliance with cGMPs and departmental procedures by promptly reporting non-compliance issues to management.
• Proposes and assist in the implementation of quality improvements to stability program.
• Effectively compile and interpret data and identify the impact of deviations to product quality and stability program in collaboration with subject matter experts.
• Supports investigations and follow corrective and preventive actions instituted.
• Ensure results reported in support of the site stability program are valid, accurate, and documented per applicable regulatory requirements.
• All other duties as assign

The Candidate

• Bachelors' degree in a related science
• Pharmaceutical experience is preferred.
• LIMS experience for data entry and sample tracking is preferred.
• Microsoft Outlook, Excel and Word experience.
• Sample handling experience (pull, log, enter in database, create labels, etc.) is preferred.
• Requires a minimum of 3 to 5 years' experience with documentation systems. Solid understanding of cGMPs as they apply to documentation and QMS.
• On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift to 40 pounds; no lifting greater than 44.09 pounds without assistance.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• Generous 401K match
• 19 days accrued PTO + 8 paid holidays

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.