Senior Quality Assurance Professional

Senior Quality Assurance Professional

Department:  Purification                                                                     

Location:        Warminster, PA

Who We Are: Shenandoah is a rapidly expanding biotechnology company specializing in the manufacture of recombinant proteins for research. We have recently transitioned into a GMP environment to support the growing Cell and Gene Therapy markets.

Who You Are: Shenandoah is seeking an experienced Protein Purification professional with proficiency in the following areas: Chromatography to include ion exchange, hydrophobic interaction, and HPLC. Familiarity with buffer exchange techniques, SDS-PAGE, Western blots, etc., scale-up and bulk production from milligram to gram quantities.

Good Manufacturing experience, documentation, and attention to detail are a must. A great candidate will possess a team-driven attitude, initiative, and a positive attitude. Good communication skills and the ability to get along well with others are essential.

Requirements: Master’s Degree in a relevant discipline and minimum 3 years of experience or BS Degree with 5+ years of experience.

Job Type: Full-time

Benefits:  Shenandoah offers medical/vision/dental as well as company-matched retirement savings.

Please email your cover letter and resume to info@shenandoah-bt.com.Location:        Warminster, PA

Who We Are: Shenandoah is a leading manufacturer of recombinant proteins for the life science community.  In 2021, we moved into our state-of-the-art facility designed to manufacture CTG™–our new GMP-grade cytokine products.   

We are ISO 9001:2015 Certified and have been certified WBENC by the Women’s Business Enterprise National Council since 2014.

At Shenandoah, rather than strive to be the largest, we strive to be the best.  We are compassionate in our work, driven by integrity, and dedicated to a superior standard of excellence.  It is important to us to create a working environment for our employees filled with respect, humor, and gratitude to give our very best to our customers.

Where we are: Shenandoah Biotechnology is located northwest of Philadelphia in Warminster, PA.  Our address is 103 Steam Whistle Drive, Unit 1, Warminster PA 18974.

Who You Are: Shenandoah is seeking a Senior Quality Assurance Professional.  

Qualifications:

  • Bachelor’s or Master’s degree in a life science field with 5 years in experience working in the quality area for an organization certified to ISO 9001, or similar standard and experience in a GMP regulated environment.
 

 Job Description:

Shenandoah Biotechnology, Inc. is seeking and experienced Quality Assurance Professional that will facilitate the development and maintenance of production quality standards and documentation. This includes but is not limited to; defining quality requirements for new products and preparing/maintaining necessary documentation, monitor production quality performance to identify opportunities for improvement, review and maintenance of quality files, procedures, batch records, protocols, work instructions, etc. for relevance and adherence to Shenandoah Biotechnology Quality System, customer and regulatory compliance. Requires a good working knowledge, comprehension, and experience with quality systems, measuring techniques and equipment in a regulated (GMP) environment. Strong verbal, written and technical skills required. Able to work with minimal supervision, demonstrate initiative and self-direction. Ability to collaborate and assist with solving practical problems. Strong interpersonal skills including teamwork, listening and giving feedback are required.

 

 Responsibilities include but are not limited to:

  • Draft, edit, revise, and update as necessary all documents associated with Standard Operating Procedures (SOPs), Quality System and Quality Manual.
  • Assistance in the Administration of Calibration, Preventative Maintenance and Environmental Monitoring programs.
  • Ensure that processes needed for the Quality System are established, implemented, and maintained.
  • Maintain and report on the performance of the Quality System and any need for improvement.
  • Ensure the promotion of awareness of customer requirements throughout the organization.
  • Administration of Corrective and Preventative Action and Change Control Systems and Customer Complaints.
  • Control of quality related documents and records and quality procedures.
  • Work closely with QA supervisor keeping them fully apprised of significant occurrences and trends that impact the quality of product or manufacturing operations.
  • Anticipate current and future issues and develops plans and actions to minimize the negative impact.
  • Work to continuously improve customer satisfaction.

Job Type: Full-time

Benefits & Perks: Competitive Compensation, Medical/Vision/Dental, Company-matched Retirement Savings

Please email your cover letter and resume to info@shenandoah-bt.com.

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