Quality Control Analyst I

Catalent Pharma Solutions; Chelsea (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

Catalent Pharma Solutions is seeking a Quality Control Analyst I at their Chelsea, MA facility. This full-time role involves executing quality control testing for product development and compliance, including analytical and microbiological analyses. Candidates should possess a Bachelor’s Degree in sciences, with a commitment to maintaining high quality standards in a fast-paced environment.

Benefits

Defined career path and annual performance reviews

Diverse and inclusive culture

Positive work environment focusing on process improvement

Community engagement and green initiatives

Generous 401K match

Medical, dental, and vision benefits effective immediately

Tuition Reimbursement

WellHub program for physical wellness

Exclusive discounts through Perkspot

Qualifications

• No experience required but preferred in cGMP regulated environment.
• Experience with QC test methods and auditing data packages is preferred.
• Familiarity with SOPs in GMP settings is an advantage.

Responsibilities

• Execute QC testing and related microbial and analytical activities.
• Conduct routine/non-routine testing of environmental monitoring samples.
• Compile data for documentation and assist in investigations.

Skills

Analytical Testing

Microbiological Assays

Data Analysis

Documentation

Laboratory Techniques

Time Management

Communication Skills

Education

Bachelor’s Degree in Physical or Chemical Sciences

Job description

Quality Control Analyst I

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 in Chelsea is hiring a Quality Control (QC) Analyst I. Quality Control Analyst is responsible for executing QC testing and related microbial and analytical activities supporting product development, release and stability. These individual conducts routine and non-routine microbial, chemical and physical analyses of environmental/utilities monitoring samples, raw materials, in-process materials and drug products according to standard operating procedures. The Quality Control Analyst 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. The Quality Control Analyst revises and updates standard operating procedures (SOPs) as needed.

This is a full-time hourly role. This is on site and the core hours are Monday – Friday 8:00AM-4:30PM .

Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Environmental Monitoring (EM) of classified cleanrooms, including total particulate, viable air and viable surface testing of ISO 8 cleanrooms
• Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction)
• Performs a variety of microbiologic assays such as bioburden, sterility testing, growth promotion testing and microorganism isolation
• Operates analytical instrumentation (i.e. Total Organic Carbon (TOC), Fourier Transform Infrared Spectroscopy (FTIR), laser diffraction, Karl Fischer); Critically analyzes data for reporting against specifications and/or protocols; Supports Laboratory and/or Quality Investigations
• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration; Prepares solutions and diluents required for analytical testing. Monitor lab supply inventory
• Participates in the construction and/or revision of SOP. 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 in Physical or Chemical Sciences (life sciences) required. No experience is required in a cGMP regulated environment, although it is highly preferred
• Experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses preferred
• Familiarity with executing Standard Operating Procedures in a GMP setting preferred
• Critical understanding of the importance of documentation and data traceability preferred
• Working knowledge of cGMP’s and their application to Quality Control preferred
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities. Excellent oral and written communication skills
• Physical requirements: Individual may be required to sit, stand, walk, and reach regularly and occasionally lift up to 50 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.