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28 days old

Quality Control Manager Uptown Seattle

Kelly Services
Seattle, WA 98194
**Quality Control Manager Uptown Seattle**


The Quality Control (QC) Manager is responsible for tasks associated with maintaining a quality management system, including hiring and managing QC personnel; scheduling of equipment and sample analysis to ensure timely reporting; evaluating and selecting vendors for supplies and labs for third party testing; analyzing materials using various instrumental and analytical techniques; coordinating and performing qualification, verification, and validation activities; and maintaining and reviewing cGXP records.


Quality Control to provide management and support of analytical testing and stability studies in support of clinical trial/drug development. This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.


**Responsibilities**


+ Ensure quality control systems and procedures meet current GMP and regulatory inspection expectations.

+ Participate collaboratively with Quality Control members and other cross-functional teams to meet company strategic plans and objectives.

+ Provide support and management of analytical technology transfer.

+ Ensure method validation and qualifications meet process and regulatory requirements.

+ Coordinate and execute sample preparation and analysis according to USP and Lumen methods utilizing capillary electrophoresis, biolayer interferometry, and other biochemical techniques.

+ Provide input and ensures the quality and completeness of investigations and changes is appropriate.

+ Proactively identify chemistry, manufacturing, gaps and risks, and support the development of mitigation plans.

+ Ensure quality and on-time delivery of drug substance and drug product testing for release and stability testing.

+ Provide direction and support for quality control for operational objectives and work plans.

+ Coordinate sample analysis with third party labs.

+ Maintain accurate records of activities.

+ Review process documentation and contribute to continuous improvements in safety, quality, and efficiency.

+ Assist with preparation and execution of internal, 3rd party audits, and other reviews.

+ Collaborate closely with Lumen management and team members, to achieve key milestones and regulatory filing timelines and annual product updates.


+ Promote the growth, training, and mentorship of subordinates.

+ Other duties, responsibilities, and activities may change or be assigned at any time with or without notice.


**Requirements**


+ 5+ years of relevant industry experience in a cGXP/FDA regulated environment such as QC or QA. At least 2 years experience in a leadership role.

+ Minimum of a bachelors degree in science, ideally in pharmaceutical industry, microbiology, or related discipline.

+ Extensive knowledge of and experience with relevant cGXP and ISO 9001 & 13485 requirements for document control and quality records.

+ Experience working with clinical and commercial products and supporting internal and external audits, and regulatory inspections.


The successful candidate will have the following attributes:


+ Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.

+ Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.

+ Capable of supporting multiple projects simultaneously in a deadline-driven environment.

+ Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment.

+ High level of proficiency in Microsoft Word, Excel, eQMS, database management and Sharepoint.

+ High integrity and ethics.

+ Commitment to quality and timely delivery of results; committed to continuous improvement.

+ Ability to work effectively at a fast pace with cross functional departments.


+ Ability to anticipate and mitigate challenges.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-05 Expires: 2022-10-06

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Quality Control Manager Uptown Seattle

Kelly Services
Seattle, WA 98194

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