Quality Control Specialist

Medexus Pharmaceuticals; United States; On-site; USD 90,000 - 110,000; Full time

Job summary

A leading specialty pharmaceutical company is seeking a Quality Control Specialist to oversee analytical work and ensure compliance with cGMP standards. The ideal candidate will have experience in biotechnology and demonstrate strong analytical and quality management skills. You will coordinate testing activities to meet clinical and commercial demand while collaborating with external laboratories.

Benefits

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Disability insurance

Qualifications

• 4+ years of industry experience in biopharmaceutical sciences preferred.
• Progressive experience in cGMP quality and testing is required.
• Strong expertise in analytical technologies and laboratory operations needed.

Responsibilities

• Oversee analytical work and maintain compliance with cGMP standards.
• Review and coordinate QC test results for product release.
• Ensure accurate release and stability testing for clinical products.

Skills

cGMP compliance

Quality Management Systems

Analytical technologies

Vendor management

Data trending

Education

BS/BA in biology, biochemistry, or related discipline

Job description

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Medexus Pharmaceuticals provided pay range

This range is provided by Medexus Pharmaceuticals. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $110,000.00/yr

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Company Bio

Medexus Pharmaceuticals Inc. is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments: Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.

Role Overview

The Quality Control Specialist will oversee and coordinate analytical work occurring at contract organizations including analytical development, in-process analysis, bioassays, and release testing for drug substance and drug product. They will ensure that analytical methods are developed and qualified/validated per cGMP and that all QC activities are conducted in accordance with global regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand. The QC specialist will support and maintain comparability, stability and method performance trending programs.

Key Responsibilities

• Works to guarantee that an appropriate cGMP Quality Management System for internal and external contract manufacturers/laboratories is developed, implemented, and managed in collaboration with Quality Assurance.
• Reviews QC test results supporting product release and stability testing.
• Coordinates with QC management to manage external cGMP laboratories by reviewing and approving documents as required, including Specifications, SOPs, protocols, reports, test methods, change requests, technical transfers, data trending, OOS/OOT investigations and deviations related to clinical and commercial requirements.
• Ensures that critical cGMP release and stability testing is accurate, compliant, and reported to meet timelines.
• Provides real-time audit support as required to assist the management team with queries.
• Remains current with USP, EP, BP, JP and ICH requirements, as applicable.
• Assist with Stability Program QC compliance and ensure the program is established and maintained for all cGMP products.
• Tracks and trends cGMP test data including performing surveillance of method performance and reference standards, and evaluation of data received from external contract laboratories.
• Compiles data for internal review meetings, Annual Product Reviews (commercial products), and all other product quality assessments.
• Supports QC with strategic planning and management of all analytical and bioassay development, qualification, and testing activities in support of clinical and commercial products.

Education, Experience, and Skill Requirements

• BS/BA with a minimum of 4+ years of industry experience, preferably in biology, biochemistry, biopharmaceutical sciences, or other biologic-science related discipline.
• Minimum 4+ years progressive cGMP quality, testing, scientific, and/or manufacturing experience in biotechnology or pharmaceuticals including biologics (e.g., protein therapeutics).
• Expertise in chemical, protein, biological and analytical technologies and laboratory operations, including experience on the bench is required. Experience with recombinant form of human factor IX or similar commercial biologics is desired.
• Working knowledge and ability to apply cGMP in conformance to U.S., EU, ROW and ICH standards
• Demonstrated ability to manage vendor relationships and coordinate testing activities with CMOs or CTOs
• Ability to multi-task and prioritize complex daily workload.
• Ability to collaborate amongst individuals
• Experience with regulatory requirements preferred

Additional Information:

• Compensation range: 90-110K
• Travel or other requirements: Travel 20%

We recognize that experience comes in many forms. Even if your background or compensation expectations don’t exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus.

Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Disability insurance

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