Quality Control Analyst III

Catalent; Chelsea (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Control Analyst II to join their dynamic team. In this role, you will execute critical QC testing and analytical activities that support product development and compliance. You will be responsible for conducting a variety of chemical and physical analyses, authoring protocols, and ensuring the highest standards of quality control. Join a firm that is dedicated to improving lives through innovative solutions and offers a supportive work environment with ample opportunities for career growth. If you are passionate about quality and compliance, this is the perfect opportunity for you.

Benefits

Defined career path

Diverse, inclusive culture

Positive working environment

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

Community engagement initiatives

WellHub program for physical wellness

Employee Resource Groups

Qualifications

• Minimum 2 years of relevant experience in a regulated environment.
• Experience with analytical method development and validation preferred.

Responsibilities

• Execute QC testing and analytical activities for product development.
• Compile data and ensure compliance with specifications.

Skills

Analytical Method Transfer

Statistical Analysis

GMP Compliance

Analytical Testing

Troubleshooting Instrumentation

Education

Bachelor’s Degree in Physical or Chemical Sciences

Tools

FTIR

Laser Diffraction

KF

XRPD

Job description

Quality Control Analyst II – Tech Transfer

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.

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Quality Control Analyst II who is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This person conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures. The Quality Control Analyst II compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results. The Quality Control Analyst revises and updates standard operating procedures as needed.

This is a full time, salaried role. The core hours are Monday – Friday 8:00AM – 5:00PM

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

• Author and execute Analytical Method Transfer protocols and reports;
• Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction);
• Operates analytical instrumentation (i.e. FTIR, laser diffraction, KF, XRPD);
• Statistically and critically analyzes data for trending and reporting into regulatory filings;
• Participates in Laboratory and/or Quality Investigations;
• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration;
• Participates in the construction and/or revision of SOPs;
• Assists in the writing and updating of analytical test procedures, protocol, log books and checklists;
• Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions;
• All other duties as assigned

The Candidate

• Bachelor’s Degree required; preferably in Physical or Chemical Sciences (life sciences);
• Minimum of two (2) years of relevant work experience required;
• One (1)+ years regulated GMP environment experience required;
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
• Experience with analytical method development and validation preferred;
• Experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required;
• Demonstrated ability to author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required;
• Working knowledge of cGMP’s and their application to Quality Control required;
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 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 + 8 paid holidays;
• Several Employee Resource Groups focusing on D&I;
• Dynamic, fast-paced work environment;
• Community engagement and green initiatives;
• Generous 401K match;
• Company match on donations to organizations;
• 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. 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 [e-mail] for us to investigate with local authorities.

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