Specialist, Facilities Compliance (QA Investigator)

Company: Disability Solutions
Location: Severn
Posted on: October 24, 2024

Job Description:

The Facility Compliance Specialist will report to the Manager of Facility Compliance. The role of the specialist is to provide support for facility quality. Provide regulatory guidance and GMP training to facilities and engineering team to maintain a high level of quality.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. 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:

• Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines.
• Generate SOP's, deviations, and change control as required for related Facilities systems.
• Support compliance effort in facilities and engineering ensuring group operates in accordance to Catalent's cGMP quality system.
• Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities.
• Support client and regulatory audits, audit responses and follow up corrective actions when required.
• Keep the leadership of Facilities and Engineering informed of abnormal or critical situations and seek advice on matters outside the specialist's knowledge or authority.
• Provide training on GMP compliance.The candidate:
  • BS degree in a technical field or equivalent experience.
  • 3 plus years of GXP quality system experience.
  • Experience in cross functional teams in a fast-paced environment.
  • Good working knowledge of facilities equipment and O&M requirements
  • Understanding of GMP compliance for facilities.
  • Strong understanding of proper OSHA safety practices and proceduresThe anticipated salary range for this position in Maryland is $93,280 - $128,260 plus an annual bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:
    • Competitive medical benefits and 401K
    • 152 hours PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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.--personal initiative. dynamic pace. meaningful work.Visit 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 . 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.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Sterling , Specialist, Facilities Compliance (QA Investigator), Other , Severn, Virginia