Specialist, QA Raw Materials

Company: Disability Solutions
Location: Severn
Posted on: October 26, 2024

Job Description:

Specialist, QA - Raw MaterialsPosition SummaryCatalent 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's Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.The Specialist, QA - Raw Materials is responsible for ensuring the quality of incoming materials and components meet quality expectations needed to assure patient safety. --Providing QA support for GMP Raw Materials that support the production of GMP Manufacturing operations. --Responsibilities include providing QA oversight of materials used for Manufacturing, Quality Control, and Process & Analytical Development.--This position is 1st shift Monday-Friday 8AM-5PM and 100% on site at our Harmans/BWI, MD facility.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:

• Conducts critical reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form) by exercising judgement within defined procedures and regulations.
• Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products; creates raw material specifications according to template requirements and information provided by technical groups; adjust the materials specification templates as needed to assure compliance with regulations and client expectations.--
• Routes specifications for review and approval through workflow in the Catalent EDMS. --Reviews, edits and revise Raw Material specifications as indicated; edits raw materials specifications as needed for client requests or supplier change notifications; creates change controls and represent QA-RM team at Change Control review board as needed; assists with the generation and/or revision of GMP documentation such as Standard Operating Procedures as it pertains to the disposition of Raw Materials
• Supports regulatory and client audit/inspections and supports internal audits of GMP systems and facilities
• Engages with technical teams and Supply Chain as necessary to proactively collect documentation for pending specifications; works with Materials Control to quarantine and disposition all GMP materials in a timely manner; works cross-functionally with Materials Control, Purchasing, Manufacturing, Quality Control and other departments to resolve raw material quality issues and provide assistance when needed
• Continually evaluates Quality and Materials Control processes and procedures to improve efficiency and ensure compliance to appropriate GMPs; reviews and approves Deviations/Change Controls/CAPAs and performs Acceptable Quality Limit (AQL) visual inspection materials, as needed
• Actively participates in training activities, managing their individual training plan.
• --Other duties as assigned.The Candidate:
  • Masters' degree in a Scientific or Life Science discipline with experience biologic, biopharmaceutical, or regulated industry preferred OR Bachelors' degree in a Scientific or Life Science discipline required with 2+ years' experience biologic, biopharmaceutical, or regulated industry.--
  • Manufacturing/Quality Assurance/Quality Control function experience preferred; Raw Materials experience is a plus
  • Experience with Good Manufacturing Practices (GMPs) and 21 CFR part 11, a plus; experience using an EDMS and ability to create workflows and reports from these systems--
  • Hands on experience with an EDMS creating documents for a GMP environment and the ability to create workflows and reports from these systems, a plus.--
  • Expert in formatting in Microsoft Word and use of edit tools.--
  • Good communication skills and ability to work in a group setting where priorities may be shifted weekly; ability to work in a cross functional team and escalate concerns related to priorities and patient first concepts; offers suggestions for correcting problems and creating more lean processes --
  • Why you should join Catalent:------- --Defined career path and annual performance review and feedback process--------- --Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--------- --Dynamic, fast-paced work environment------- --Generous 401K match and Paid Time Off accrual--------- --Medical, dental and vision benefits effective day one of employment--------- --Tuition Reimbursement--------- --Wellhub program to promote overall physical wellness--------- --Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent 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, Reston , Specialist, QA Raw Materials, Other , Severn, Virginia