Job Title - QA Associate III Duration - 06 Months Location: Athens, GA 30601
Roles and Responsibilities:
Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.
Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
Information must be proactively shared across QA and the business including the on-going training of junior team members.
Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations.
Works closely with others to determine root cause and potential preventative/corrective actions.
Ensures support for the timely closure of investigations.
Provides guidance directives regarding remediation activities required to continue production.
Oversees execution of remediation/CAPA activities required to continue production or move a process along. Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities.
Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.
Ensures all specifications are met and that requirements are completed and acceptable.
Ensures all issues/documentation associated with each process in the assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
Analyze and report findings to appropriate departments.
Works closely with others to recognize opportunities for improvement and drive change through the use of client’s Quality Systems.
Skills:
Capability to establish good relationships with others who have different values, cultural styles and perspectives.
Setting high and ambitious goals and standards for oneself and others continuously raises the bar.
5-7 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.
Strong independent judgment and decision-making abilities are required.
Project management experience Strong knowledge of relevant regulatory guidance.
Demonstrated problem-detection and problem-resolution skills required. Strong conflict resolution and negotiation skills are required.
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills
good interpersonal skills.
Proficient in SAP
Education:
Bachelor's degree in Life Sciences or Engineering
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.
