What are the responsibilities and job description for the Quality Assurance Specialist position at Computech Corporation?
About Us:
Computech Corporation has over 25 years of experience providing contract, temporary, and direct-hire staffing services. We successfully work with public and private sector entities nationwide and offer staffing solutions for Information Technology (IT), engineering, medical, professional, finance, administrative, light industrial, manufacturing, and other workforce needs.
Job Title: QA Specialist
SHIFT available:
1.MON-FRI 6AM - 2:30PM
2.FRI, SAT, SUN 6AM - 6PM.
3.FRI, SAT, SUN 6PM - 6AM
Duration: TEMP TO HIRE after 6 months
Location: 110 1100 Enterprise Drive 13-4268760 Winchester KY 40391
ONSITE POSITION
Position Overview:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
II. Specific Tasks, Duties and Responsibilities:
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products..
- Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
- Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
- Other assignments as needed within the scope of QA Associate training curriculum.
- Assist in investigations for deviations by supporting data gathering and root cause analysis
- Enforcement of GMP Compliance.
- Promotes team work and good communication.
- Provide training and coaching to manufacturing staff as needed
- Support site process improvements (training, efficiency projects, implementation of CAPAs)
- Supports customer complaint investigation by performing inspection of retains and
Education or Experience: (Minimum required to perform job)
- Preferred - Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
- Minimum of High School Diploma in combination with 4 years of relevant work experience in a regulated GMP manufacturing environment.
- Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
Job Types: Full-time, Contract
Pay: $24.00 - $27.60 per hour
Expected hours: No less than 40 per week
Schedule:
- 10 hour shift
- 12 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
- Night shift
- Weekends as needed
Education:
- High school or equivalent (Required)
Experience:
- manufacturing operations: 2 years (Required)
- Pharmaceutical: 2 years (Preferred)
- CGMP: 2 years (Preferred)
Shift availability:
- Day Shift (Preferred)
- Night Shift (Preferred)
- Overnight Shift (Preferred)
Work Location: In person
Salary : $24 - $28
