Quality Operations Specialist – 1st Shift

Job Description

“OVERVIEW
The QA Associate is responsible for the Quality support functions associated with the manufacturing. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Company SOP) through document review/approval and real time monitoring/approval of manufacturing activities.

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
• 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 for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Maintain a full understanding of all Company SOPs and policies along with all cGMP and CFR guidance that are applicable to manufacturing.
• 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.
• Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
• 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 complaint samples
Essential Skills and Experience:
Education or Experience:
• Bachelor’s Degree in related science or technical field preferred with 2 years prior work experience
• Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.

Knowledge/Skills Requirements:
• Safe work habits
• Basic math and computer skills
• Good communication skills
• Ability to follow written and verbal instructions
• Able to work with limited supervision for routine tasks
• Excellent documentation and handwriting skills
• Proficient reading and comprehension skills
• Sound decision-making, technical and problem-solving skills
• Good time management skills
• Expert technical writing and problem-solving skills
• Experienced with continuous improvement techniques
• Demonstrates initiative ”

This position will be working with a team of 5 in a manufacturing environment. It is a fast-paced position and REQUIRES attention to detail. Must be dependable and a self-starter. Must have prior QA in a regulated environment. Personal Protective Equipment is also REQUIRED. Basic excel, MS Office including Outlook. Education Requirements: BS Preferred. MIN PRIOR EXP REQUIRED: 2-4 years in a regulated environment.