"Alerted.org

Duration:** **12** **months contract

**Shift** : 1st shift, 8 AM – 5 PM, Monday through Friday

**Overtime:** Possible during project peaks; no fixed schedule established.

Job Description:

+ This position supports client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas.

+ The ideal candidate is a detail-oriented Quality Assurance professional with at least 2 years of GMP experience in a regulated manufacturing environment, preferably within pharmaceuticals or medical devices.

+ They should bring a solid understanding of QA documentation processes, including change controls, equipment qualifications, and master data approvals, and be comfortable working within SAP or EPR systems.

+ Strong project coordination skills and organizational discipline are essential, as this role supports a large-scale product launch and will require managing multiple deliverables on tight timelines.

+ A background in process development, manufacturing, or digital quality innovation is highly desirable.

Responsibilities:

+ Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems.

+ Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.

+ Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion.

+ The QA Specialist will also represent QA Functional area in the execution of projects necessary to achieve departmental operational goals.

Preferred Qualifications:

+ Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field.

+ Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.

+ Experience managing projects through to completion meeting timelines.

+ Evaluating documentation and operations according to company procedures.

+ Experience working with Quality Systems Strong organizational skills and ability to manage multiple tasks at one time

+ Effective communication skills (both written and verbal).

+ Demonstrated ability to work as both a team player and independently.

+ Display leadership attributes and drive improvement initiatives.

Top 3 must have skills:

+ Experience in and knowledge of GMP/GCP operations or similarly regulated industry

+ Affinity with digital innovation, data sciences and Quality engineering

+ Highly effective verbal and written communication skills, strong interpersonal skills

+ Great attention to detail and high degree of accuracy in task execution and GMP documentation

+ Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"