Production Quality Control Specialist Jobs in Texas

Aides to ensure that the quality system requirements are maintained.

Ensure quality assurance assessments at established supplier and client sites are performed in compliance with Company requirements

Manage and support issues in relation to scan docs.

Computer software skills including Microsoft Office, Word, Excel, Access, and Oracle (ERP) system.

Knowledge in API, ISO, and ASTM standards preferred

Review Source Documents including material test records to ensure quality, completeness, and accuracy to engineering specifications.

Excellent interpersonal, verbal and written communication skills with strong technical writing experience.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Chemistry, Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.

Extensive knowledge of GLP and GDocP principles.

Capable of delivering to assigned work schedule with attention to detail and accuracy.

Support department risk assessments and participates in audit walk-throughs.

Job Requirements; Knowledge, Skills, Abilities, and Accountability:

Bachelor’s degree; or combination of education and experience.

Minimum 5 years’ successful experience in college financial aid in post-secondary educational environment.

Wide knowledge of regulatory requirements (e.g., federal, state, etc.) related to Title IV student financial aid.

Basic knowledge of CampusVue database (preferred)

Vice President of Financial Aid

Report OOT/OOS results and other deviations to area management and help remediate issues

Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections

Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements

Typically requires 4+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Participate in executing and/or review of method validations, method transfers and/or equipment qualification/requalification

The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential

Bachelor or Master degree in Comp. Science, Engineering or other relevant technical field, or equivalent combination of work experience and education

Solid knowledge of networking, routing, switching, firewalls, routers, etc.

Previous hands on experience in identifying product failure modes and conducting root cause analysis is required.

Previous experience of using scripting tools (e.g. pl, Python, etc.) for product quality data analysis is a plus.

Previous experience of participating in ISO audit is a plus.

Excellent verbal and written communications and people skills.

Reports directly to Quality Control Lead/Manager

Completes Data Entry of all requests

Knowledge of grammar and punctuation

Entry level job duties include but not limited to

Entering data into database software and checking to ensure the accuracy of the data that has been inputted.

Resolving discrepancies in information and obtaining further information for incomplete documents.

Quality Control Specialist III Experience, Education, Skills, Abilities requested:

BA, BS or MS. Experience with laboratory quality management systems.

Support and comply with program’s specimen management policy

Knowledge of CLIA, GLP, GMP, ISO, and FDA regulatory requirements

Comply with LQMS program requirements and applicable CLIA, GLP, GMP, ISO, and FDA regulatory requirements

Maintain supplies inventory, order, and inspect products under applicable guidelines and regulatory requirements

Responsible for ensuring all UL and FM compliance requirements are continually adhered to.

Bachelor’s degree in engineering or related field or equivalent job experience is desired.

Previous experience in a Quality Control or Quality Assurance role in a manufacturing environment, preferably plastics processing.

Trains production team on quality control measures to improve product excellence.

Create common business-specific quality measurements and track improvement against these metrics.

Plan and coordinate the work activities for inspecting products in a lab environment.

Knowledge and application of the USACE Construction Quality Management requirements.

Current USACE “Construction Quality Management for Contractors” certification, or ability to obtain, is desired.

Technical knowledge of the application of procurement and construction practices sufficient to comprehend Quality requirements, including interpreting drawings and specifications.

Inspect (or oversee inspection of) materials and equipment received on site to assure compliance with contractual requirements.

Experience participating in and supporting quality assessments, surveillances, and audits.

Minimum of Associates degree or equivalent experience.

Assist in the implementation and qualification of new assays

Write, edit and approve deviations and CAPAs as required. Responsible for initiating change controls and completing necessary documentation

May initiate out of specification (OOS) and deviation investigations as needed to address non-conformances in the lab

Assist in tracking and trending of QC data

Responsible for completing, organizing and filing data. Will need to follow up and modify with documents to reflect complete testing

Perform technical reviews of raw data

Strong verbal and written skills

Weekly labor voucher audit and CVP focal for the site. This includes CVP reverification and revocation/reauthorization.

Assist operators to access CVP training slides, administer and grade CVP test.

Maintain, update e-CVP file with completed CVP annual reverification along with e-CVP revocation and reauthorization.

Responsible for Workstation and special process audits

Focal for stamp control for the site. This includes issuing new stamps, revoke and reissue as needed.