Quality Assurance Specialist (GMP Data Review) (In-Person)

The Company:   

Pace® Analytical Life Sciences (PLS) is an industry leading contract laboratory, supplying analytical chemistry and microbiology services to the Medical Device, Pharmaceutical, Biopharmaceutical industries. Since our formation in 2006 we have grown at a rate of over 15% per year and established ourselves as one of the top ten contract laboratories within the United States providing cGMP services to a wide range of clients worldwide. We attribute our rapid growth to our solid quality system combined with an exceptional culture of client service.   

Compensation: $50,000 to $55,000.00 per year

Summary:   

We are actively seeking a candidate to join our Quality Assurance (QA) Data Review team as a Quality Assurance Specialist II. The ideal candidate is one who thrives working in a highly dynamic, team-oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical and medical device products.   

The Quality Assurance Specialist II is responsible for review of laboratory technical records. Laboratory testing can be documented on paper worksheets or in an electronic laboratory notebook. Laboratory testing varies from raw materials testing (e.g. USP, BP, EP), in-process, finished product release and stability studies.  The tests vary in complexity from simple wet chemistry tests (e.g. visual titrations, residue on ignition) to biopharmaceutical techniques (e.g. ELISA, capillary electrophoresis) to more complex instrumental techniques (e.g. HPLC, HPLC-MS, GC, GC-MS, ICP-MS, MS-ToF).  The Quality Assurance Specialist II reports to a QA Group Leader or QA Manager.   

The ideal candidate is one who has a strong attention to detail and organization skills and is comfortable working independently.  The ideal candidate is also self-motivated, demonstrating a strong work ethic and flexibility to adapt to a dynamic work environment and changes in work priorities.  The ideal candidate thrives in a collaborative environment and is comfortable working with various departments toward a common goal of delivering client data and analysis reports by the due date.   PLS encourages cross-training to develop new knowledge and skill sets.  The ideal candidate is one who thrives in an environment of continual learning and growth.    

Preferred qualifications include previous GMP laboratory or QA data review experience in various analytical techniques, such as UV-VIS spectrophotometry, HPLC, GC, HPLC-MSICP-MS, ELISA, and capillary electrophoresis. Experience with data acquisition software such as Empower and MassHunter is preferable.    Previous experience with biopharmaceutical techniques, method development and validation, and stability studies would be ideal.  

 Job Responsibilities:   

· Perform data review of laboratory technical records for quality system compliance while ensuring that client due dates are met 

· Provide support to other members of the QA Data Review Team 

· Review and approve final analysis reports 

· Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications (e.g., ELN, LIMS, Empower).  

· Assure all work performed is compliant with PLS SOPs and the quality management system 

· Become familiar and regularly updated with quality and regulatory policies associated with the technical area.   

· Participate in ongoing quality, cGMP, safety, method and technique training   

· Other tasks as assigned by QA Management   

 Requirements:   

· Keen attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment   

· Strong interpersonal skills   

· Strong verbal and written communication skills   

· Ability to excel in a fast-paced work environment   

· Ability to work independently, multi-task and be flexible with changing priorities   

· Bachelor’s Degree in Chemistry or other science-related discipline   

· Two years of laboratory experience, preferably in an FDA regulated laboratory environment    

· Empower experience is preferred   

Physical/Mental Requirements: 

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Mobility to work in an office setting, use standard office equipment and stamina to sit for extended periods of time; strength to lift and carry up to 10 pounds; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone. 

Working Environment:  

Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.