SGS North America
Data Reviewer - Biologics
At a glance
Location: US-PA-West Chester Map
Posted: 02/26/2021
Closing: 03/25/2021
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
SGS North America
Job description

Company Description  

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.


Job Description  

PRIMARY RESPONSIBILITIES

The Data Reviewer 1 is responsible for review and approval of data generated in the laboratory in a timely and effective manner according to methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs) of SGS Life Science Services Analytical Laboratories and Departments. This job also requires the ability to demonstrate a high commitment to interpersonal relations.  

Follow Training SOP for training and training records.

REPORTING LINE

The Data Reviewer Level 1 in the Biologics Deparment at SGS reports to the Department Head or Assigned Manager.

SPECIFIC RESPONSIBILITIES

 
•       Perform data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include biologics and instrumentation data reviews.


•       Perform reviews for reagent and standard preparations and their assays or suitability testing and/or media preparation and associated media checks. Perform equipment performance logs review, auxiliary log book reviews, stability study pull reviews, audit trail reviews and metrology reviews.


•       Perform special project data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include biologics and instrumentation data reviews .


•       Perform Out of Specification (OOS) and Method Validation Failure (MVF) biologics investigations following staff performance of customer test requests in a timely and effective manner.


•       Ensure that all testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications.


•       Ensure that all reasonable requests from Department Management pertaining to review of laboratory data supporting a given test or group of tests are met in a timely and effective manner.


•       Play a role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.


•       Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory.


•       Assures that reviewed QC records are compliant to methods, specifications and company’s applicable Standard Operating Procedures.


•       The review is done according to Data Review SOP


•       Identifies area for improvement of SGS SOPs, analytical methods and forms. 


•       Follows deadlines specified on a lab sheet or as scheduled by their supervisor.


•       Assures records of Method Validation/Method Transfer/Method Verification and reports are as per protocol and method provided by clients or written by SGS


•       Assures that OOS and deviations are closed before forwarding the records to QA for release of C of A.


•       Ensures test results are reported appropriately on either a Certificate of Analysis or a Certificate of Testing depending on the validation/transfer status of the method.


•       Assures review of data in a timely manner and approval of records prior due date.


•       Assures method development records are reviewed as per SGS SOPs;


•       Issues an audit form noting deficiencies to method and procedures, returns the form to analyst for correction according to Data Review SOP; Ensures that all valid deficiencies are corrected; escalates all concerns to management.


•       Informs analyst or his/her supervisor to initiate out -of-specification and/or issue OOS form in case of OOS, which was not noted by analyst;


•       Audits all record books (log-books) associated with testing reviewed / approved;


•       Ensures that documentation review is complete in every respect and reviews that all results are entered into the electronic laboratory information system LIMS.


•       Attends training sessions and ensures that training binder is current. Has a training record for every SOP version executed, if applicable; If absent during training sessions, ensures training is performed and documented;


•       Reviews and approves solution preparations and labeling;


•       Requests training if work assigned requires knowledge of SOP with no record of training or reads and asks questions about SOPs in training;


•       Audits calibration related documents and other QC documents;


•       Inputs data for trending departmental KPIs;


•       Identifies, participates in and sometimes leads operational improvement initiatives.


•       Minor participation in regulatory, and client audits needed. 


Qualifications  

PROFILE


•       Education: B.S. in Biochemistry, Chemistry, Biology or equivalent.  


•       Experience: 0- 2 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company. 

REQUIRED SKILLS


•       Ability to critically evaluate and review almost all test records generated by SGS


•       Comfortable with electronic systems (e.g. LIMS) and other lab equipment to be able to perform audit trail of testing records


•       Experience and understanding of HPLC data


•       Able / willing to learn new skills (review of new tests, instrumentation and procedures) as required and follow directions from management including priorities


•       Technically competent


•       Ability to learn quickly in a challenging environment.


•       Excellent language, writing and communication skills required.


•       Thorough knowledge of scientific principles pertaining to analytical records reviewed


•       Ability to interpret, analyze data and draw logical conclusions required.


•       Must be well organized and able to work effectively and efficiently.


•       Ability to work well with others, independently and fostering teamwork throughout the laboratory


•       Proven time management skills and a strong attention to detail


•       Responsible to deadlines


•       Proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook, LIMS and equipment software).


•       Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.


•       Appropriate attitude, constant vigilance, attention to detail and following Training SOP for training and training records.


•       As per SOP PSL-311-06 all employees must maintain appropriate attitude, constant vigilance and attention to detail. Understanding of the lab quality control / quality assurance processes, GMP and GDP as it relates to pharmaceutical testing


Additional Information  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

SGS is an EOE AA M/F/Vet/Disability employer.                                                                                

Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will be called back shortly. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Data Reviewer - Biologics