Fairfield, NJ, United States
Job DescriptionnPRIMARY RESPONSIBILITIES The Quality Assurance Specialist 1 is responsible for assisting management with the maintenance of the Quality Systems at SGS. Assignments are generally provided by a Team Leader or Manager. The Quality Assurance Specialist 1 must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations. This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to SGS customer base. REPORTING LINE The Quality Assurance Specialist 1 in the Quality Assurance Unit at SGS Life Science Services reports to Quality Assurance Management. SPECIFIC RESPONSIBILITIES OUR PROMISE TO OUR CUSTOMERS At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to the highest level of cGMP compliance. SERVICE RESPONSIBILITIES TO CUSTOMERS • Ensure that all customer requests for information pertaining to SGS services are met in a timely and effective manner. • Help in the documentation and resolution of customer complaints. • Issue Certificate of Analyses in a timely manner • Review and approval of method transfer and validation reports • Host customer audits of the laboratory SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS • 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. • Provide support in the maintenance of Quality Assurance processes, such as OOS investigations, deviation reporting, vendor approval, internal audits, trending, and other quality systems as directed by Quality management. TECHNICAL RESPONSIBILITIES • Maintain thorough knowledge and understanding of all general SOPs pertaining to the laboratory. • Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory. • May be invited to participate in the preparation and review process for appropriate department SOPs, worksheets and data forms. ADMINISTRATIVE RESPONSIBILITIES • Adherence to relevant SOPs governing documentation and reporting. • Compliance with applicable SOPs related to the handling of customer complaints. • Adherence to applicable personnel policies regarding time clock, telephones, sick days, vacation days, etc. • Participation in general staff training sessions as these are scheduled. • Approve and issue Certificate of Analysis and sign on cGMP related reports. nnJob RequirementsnEDUCATION/EXPERIENCE • B.S. in Chemistry, Biology, Microbiology or equivalent experience required. • Thorough knowledge of scientific principles required. • Job requires mobile use of hands and arms. Reasonable accommodations will be made for persons with disabilities. • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day. REQUIRED SKILLS • Highest commitment to GMPs with regard to the recording of laboratory data for testing of pharmaceuticals and medical devices. • Excellent language and communication skills required. • Must be able to clearly communicate responsibilities of solid documentation needs on a daily basis. • Good listening skills are essential. • Must be able to work with a diverse group of individuals performing bench testing. • Must have a solid grasp of the fundamentals and importance of teamwork in the contemporary business world. OTHER INFORMATION: • Safety is a top priority within SGS. Every employee within the organization has defined HSE Duties and Responsibilities to ensure that the organization meets its objectives of no harm to personnel, damage to equipment, or harm to the environment. • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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 Equal Opportunity Employer. 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 [ Phone number blocked ] 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.