SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
OUR PROMISE TO OUR CUSTOMERS
At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.
SERVICE RESPONSIBILITIES TO CUSTOMERS
• Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner. • Ensure that all client requests for information pertaining to analytical testing (or any SGS other services) are met in a timely and effective manner. • Ensure that routine testing submitted by client is completed within established parameters governing turnaround time, and quality expectations. • Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner. May act as staff liaison for certain specialized testing elements performed routinely for selected clients. • Participation in departmental and/or company-wide projects designed to improve the nature of SGS client services.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
• Work as a team with other Analysts and communicate effectively with peers and superiors. • Report and Assist in the failure investigations as instructed. • With limited supervision, prepare study protocols, study reports, forms and SOP's. • Is comfortable leading and/or participating in technical conversations with SGS clients. Inform the Department Manager and/or Group Leader/Scientific Leader, as far in advance as possible, if the assigned work order cannot be satisfactorily completed within established scheduled time and quality of work expectations. • Perform additional assigned lab duties and periodically update Department Manager and/or Group Leader/Scientific Leader on the status. • Keep the work area clean and organized; immediately clean up spills, dispose of waste according to laboratory procedures and place used glassware in designated locations for cleaning. • Maintain clean and organized workbench area ensuring spills are immediately cleaned; disposal is according to laboratory procedures, glassware is appropriately handled and lab solutions are replaced. • Assist in the resolution of routine, as well as non-routine technical problems. • Ability to step in when the Group/Scientific Leader is not available to be able to answer technical queries as well as help fellow Analysts. • Assist the Department Manager/Scientific Leader to manage large projects and programs. • Trouble shooting instrument malfunction or method execution problems; assist the junior analyst with the difficulties in testing. • Possess the ability to make procedural and technical recommendations for improvement with a firm understanding of the regulatory framework. • Contact Department Manager and/or Group/Scientific Leader if there are any doubts regarding incumbent's ability to fulfill test requirements satisfactorily. • Based on sound knowledge of methods/procedures/policies conduct trouble shooting and investigations to the point of presenting cause identification and solution to Department Manager and/or Scientific Leader. • Attend training sessions and inform the Department Manager and/or Group Leader/Scientific Leader if there is any doubt regarding the ability to fulfill testing requirements satisfactorily. • Show initiative in completing work orders and providing solutions for effective lab performance.
• Execute and perform testing as per methods, following the company's Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines. • Duties here include preparation for testing by using good time management skills for each assigned task, such as confirming availability of resources (standards, equipment, etc.) and adequacy of testing documentation, proper application of test procedures, proper technique for data capture and recording, and preparation of the final report of analysis. • Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing. • Prepare and standardize Test solutions, Standard solutions and Volumetric solutions. • Ensure that equipment are maintained in good order, perform calibrations and qualifications as required. • Perform routine and more complex analysis/testing of pharmaceutical and biopharmaceutical finished products and raw materials. • Ability to execute method verifications, validations, transfers based on signed protocols with little supervision. • Record data in timely manner. • Has a high technical aptitude with an understanding of the techniques and procedures employed as well as a background understanding of the analyte of interest. • Capable of multi-tasking with great accuracy and efficiency • Be capable to execute new, and/or complicated method development with minimal guidance. • Constantly look for ways to improve analytical techniques, documentation and daily work duties. • Conduct trouble shooting where testing/analytical failures occur in liaison with Group/Scientific Leader and designate. • Prioritize, schedule and plan daily work in order to maintain efficient work flow to assure completion of scheduled tasks and to meet established due dates. • Record findings in standardized format, keeping all records and analyst notebook in good order.
• Adherence to relevant SGS SOPs governing documentation and reporting. • Adherence to applicable SGS personnel policies regarding time clock, telephones, sick days, vacation days, etc. • Compliance with applicable SGS SOPs related to the handling of client complaints. • Participation in general staff training sessions as these are scheduled. • Participate in training sessions in the proposal, investigation and introduction of new technologies and services for SGS • Ensures full compliance with the company's Health & Safety, Code of Integrity, and Professional Conduct policies.
EDUCATION/EXPERIENCE • Education: B.S. in Biochemistry, Chemistry or equivalent. • Experience: Over 3 years of analytical laboratory experience with demonstrated ability to complete more complex role/duties. REQUIRED SKILLS Specific technical skills: • Hand/Eye coordination, ability to stand out, think outside the box. • Able to read, understand and follow work instructions in a safe, accurate and timely manner. • Proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook). • Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment. • Demonstrates excellent verbal and written communication skills. • Ability to work well with others & independently. • Proven time management skills and a strong attention to detail. • Works well under pressure. • Demonstrated understanding of protein biochemistry, cell biology, molecular biology, and/or biophysics.
Technical competency in two or more of the following is preferred: • HPLC, UPLC, and general chromatography experience. • Ion exchange, size exclusion, reversed phase, hydrophobic interaction. • Capillary Isoelectric Focusing, and 2D-Gel Electrophoresis • SDS-PAGE, Native PAGE, cSDS, Western Blot • ELISA • Enzyme assay • DNA isolation, restriction enzyme digestion, PCR, qPCR • Cell culture, Cell based bioassay • Protein expression and purification. • Structure and Function Biochemistry