Quality Control Manager

Are you an experienced quality control manager ready to take on a new challenge?

If your answer is an enthusiastic “yes” then please keep reading!

Our Quality team is looking for a new Quality Control Manager to join their team.

Who is MedPharm?

We are a team of scientists and innovators developing new formulations and models for the topical and transdermal drug market. We have established a worldwide reputation for delivering exceptional solutions over the past 20 years and have continued to expand operations in our US facilities. 

What does a Quality Control Manager do?

The QC manager is responsible for managing the day to day laboratory activities for testing and release of finished product and stability samples of topicals ( Clinical and commercial material). The Manager will also provide the leadership necessary to support the business needs of the site and achieve outstanding product quality. These activities include the establishment, implementation, maintenance, and improvement of select Quality procedures and processes.

What are we looking for?

We are looking for a detail-oriented quality control manager to ensure the manufacturing production run smoothly and generate a consistently suitable output of products that meet quality and efficiency standards. They should be able to understand the customer's needs and requirements and coordinates employee efforts and communications between management and the production team. You should have excellent communication and listening skills, with strong observational, analytical, and problem-solving skills. You should understand regulatory compliance and be skilled in understanding scientific and technical data. 

Perks of working at MedPharm

• Paid to work with amazing people
• Great Coffee Machine (Serves Hot Chocolate Too!)
• Health/Dental/Vision Insurance
• Flexible Schedule
• Life Insurance
• FSA/HSA
• 401k
• Tuition Assistance
• Free Gym Access
• Professional Development Classes
• Work/Life Balance
• Social Events
• Financial Planning

Position Summary

Position title: Quality Control Manager

Reports to: Vice President of Quality

Anticipated Hiring Range: $100,000-105,000

Essential Duties and Responsibilities

• Follows, adheres and enforces GLP, GMP, GDP, USP, ICH guidelines, MedPharm procedures and Policies.
• Manage routine operations and oversee scheduling and release of finished product and stability testing.
• Review and approve stability protocols describing the required testing for topical drug products (Clinical and commercial) manufactured at the Durham site.
• Review and approval of all types of testing conducted within the laboratory.
• Author, review, approve and train lab personnel on new and revised quality documents (specifications, analytical test methods, SOPs, protocols, technical documents, etc.) in support of product testing and continued improvement to the Quality System.
• Responsible for the preparation of laboratory investigations, root cause analysis, Corrective and Preventive Action (CAPA) plans related to deviations, laboratory incidents, and Out-of-Specification events.
• Manage and monitor on-time closure of laboratory investigations, deviations, and investigations .
• Support new product development through timely testing of exhibit batches and stability.  Prepare COAs and other documents, as required.
• Support analytical testing method transfer into the Quality Control Lab.
• Keep upper management informed of all key quality findings and issues.
• Coordinate the shipment of samples to 3rd  Party approved laboratory as needed.
• Performs product, data, and trend analyses to support organizational needs and continuous improvement activities. (i.e. process trending, quality  KP’s, Quality Review Meeting etc.)   
• Provide   leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality standards.
• Develop a highly engaged, self-empowered and capable team through goal setting, mentoring, talent development activities, and reviews.
• Drive continuous improvement objectives and initiatives. Leads or participates in quality improvement projects.
• Troubleshoots HPLC testing and other lab instrumentation with bench chemists as needed.
• Ensure the lab equipment is maintained and calibrated according to company policies and procedures.
• Participates, review and approve laboratory equipment qualification/validation documents as required.
• Generates, review or approve Change Control documents and impact assessments to ensure compliance for laboratory activities.
• Escalates any quality issues immediately to Quality Assurance management
• Maintains knowledge of current regulatory requirements pertaining to pharmaceutical manufacture and testing according to applicable regulations.
• Maintain effective communication and partnership with all departments across the organization
• Provides support for regulatory inspections and client audits, if required.
• Any other duties and/or tasks that may be assigned.

Candidate Requirements

Education

• Bachelor's degree in related field (Chemistry, Biology, or other technical or physical/life science) with 3-5 years of relevant experience.
• Good knowledge and understanding of cGMP or GLP regulations as detailed in 21CFR and ICH guidelines

Experience/Traits/Skills

• Must have a meticulous approach to work and be highly organized.
• Good communication skills, both written and oral.
• Must have a collaborative approach to problem solving. 
• Must be able to multitask, manage time efficiently and be able to prioritize.
• Must be able to work independently and in a team environment.

MedPharm Ltd is an equal opportunity employer and prohibits discrimination and harassment of any kind. We are committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job app

Salary : $100,000 - $105,000