Operations Quality Specialist

Catalent Pharma Solutions; Malvern (Chester County); On-site; USD 45,000 - 75,000; Full time

Job summary

An established industry player is seeking an Operations Quality Specialist to ensure the highest quality standards in product manufacturing. This full-time role involves reviewing batch records, monitoring production schedules, and educating teams on compliance with regulations. Join a dynamic environment that prioritizes patient safety and quality, while offering a defined career path and opportunities for growth. With a commitment to innovation and excellence, this organization is dedicated to making a positive impact on health outcomes globally. If you are passionate about quality and compliance, this is the perfect opportunity to enhance your career.

Benefits

Defined career path

Diverse, inclusive culture

Positive working environment

152 hours of PTO + 8 paid holidays

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

WellHub program

Community engagement initiatives

Dynamic, fast-paced work environment

Qualifications

• High School diploma with 2 years' experience in a regulated industry required.
• Bachelor's Degree highly preferred.

Responsibilities

• Review and approve all batch records prior to production.
• Communicate with functions to resolve inconsistencies in batch records.
• Ensure timely release of batches and raw materials.

Skills

Good Computer Skills

Knowledge of FDA cGMP's

Good math skills

Education

High School diploma

Bachelor's Degree

Tools

MS Office

Job description

Operations Quality Specialist page is loaded

Operations Quality Specialist

Apply locations Malvern, PA time type Full time posted on Posted Today time left to apply End Date: May 15, 2025 (28 days left to apply) job requisition id 0088740

Operations Quality Specialist

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions is hiring an Operations Quality Specialist. The Operations Quality Specialist ensures all the products and services offered by Catalent are of the highest quality in terms of satisfaction, predictability, and sustainability.

This is a full-time role position: Monday-Thursday 12:00pm-10:30pm. 2nd shift. Onsite.

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

• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and SOP requirements. Ensure that any changes are performed according to procedures.

• Monitor schedule for production priorities.

• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.

• Educate other functions to ensure compliance with regulations, procedures, and client requirements.

• Ensure timely release of batch. Release batch within MRP System. Review and release raw materials.

• Record and track errors and right-first time to maintain departmental metrics.

• Archive batch documents onto shared drive and within archive room.

• Ensure that responsibilities are completed efficiently while maintaining Quality.

• Review operations investigations.

• Edit SOPs applicable to operations.

• All other duties as assigned.

The Candidate

• Required a High School diploma with two years’ experience in a regulated industry.

• Bachelor's Degree highly preferred.

• Good Computer Skills. Knowledge of MS Office and programs associated with the position desired.

• Good knowledge of the application of FDA cGMP’s is a must.

• Good math skills preferred.

• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture.

• Positive working environment focusing on continually improving processes to remain innovative.

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

• 152 hours of PTO + 8 paid holidays.

• Several Employee Resource Groups focusing on D&I.

• Dynamic, fast-paced work environment.

• Community engagement and green initiatives.

• Generous 401K match.

• Medical, dental and vision benefits effective day one of employment.

• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

• WellHub- program to promote overall physical wellness.

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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.

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 [e-mail] . This option is reserved for individuals who require accommodation due to a disability.

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 [e-mail] for us to investigate with local authorities.

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

About Us

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

• You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

• You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

• You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

• You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

• You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

• See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.