Job Summary:

Perform Quality Assurance (QA) functions to build, uphold, and improve the Company’s Quality Systems.

Essential Duties and Responsibilities:

• Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
• Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
• Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
• Perform training and manage the Quality System’s Training Program.
• Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
• Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
• Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
• Make changes to SOPs, policies, training materials, and other documents in the records management system.
• Assist during regulatory inspections.
• Interface with various Divisions in problem resolution, and continual improvement.
• Support manufacturing failure investigations, define investigational strategy.
• Facilitate meetings.
• Apply discretion in decision making.
• Demonstrate independent judgment and make recommendations regarding business practices.
• Formulate, implement, interpret and affect policies and operating practices.
• Communicate effectively with others.
• Maintain a good attendance record.
• Perform work onsite.
• Perform other duties as assigned.
• Perform at an experienced and functional level therefore requiring limited supervision.
• Engage in Professional Development Activities

Required Education, Knowledge, Skills, Abilities:

• Bachelor’s degree, preferably in Chemistry or in physical or biological science.
• Minimum 3 years experience in an Food and Drug Administration (FDA) regulated manufacturing environment.
• Minimum 1 year experience training in a business setting.
• Minimum 3 years of progressive experience in Quality Assurance .
• Demonstratable strong written and verbal communication skills.
• Excellent organizational skills.
• Proven record of excellent documentation skills.
• FDA & OSHA trained and familiar with current regulations.
• Strong problem solving skills.
• Project management and technical software skills (Excel, Access, etc.) required.
• Work well under pressure and able to prioritize workloads.
• Ability to perform risk assessment.
• Experiece fostering teamwork to get results.
• Well organized and multi-task oriented.
• Ability to work independently on multiple projects.
• Ability to read, write and speak English competently.

Preferred Knowledge, Certifications, Skills, Abilities:

• Worked in pharmaceutical or cosmetic mfg environment.
• American Society for Quality certifications.
• Project management experience.
• Experience training safety, quality and GMPs.

Environmental Conditions:

• Primarily office environment – climate controlled.
• Periodic visits to:
• Warehouse environment – some temperature extremes, dust and noise.
• Manufacturing environment - some temperature extremes, dust, noise and wet.
• Potential exposure to hazardous chemicals.
• Requires use of PPE such as safety glasses, hairnets, or gloves.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Omaha, NE 68137: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality assurance: 1 year (Required)
• Microsoft Excel: 1 year (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

Please Note :
epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.