Quality Assurance Quality Control Jobs in Union, Iowa

Consult with local management in determining best measures of project efficiency.

Supports development of internal process controls, strategies, and techniques that ensure SOSi exceeds contractual requirements.

Responsible for all activities involving quality assurance and compliance with applicable contract and regulatory requirements.

Implement and manage the QA/QC and Environmental/Safety program.

Five years of progressively responsible experience in quality assurance/quality control operations.

Has knowledge of commonly-used concepts, practices, and procedures within the medical and/or public health field.

Professional growth opportunities including paid education and certifications

5. Works closely with management to ensure adherence to ISO standards and NAVSEA Standard Items.

16. Knowledge in Welder Qualification is a plus.

9. May provide guidance and work leadership to less-experienced staff members.

12. Electrical Cableway and Connector knowledge a plus.

13. May require professional, technical, or company certification(s), depending on job assignment.

Outstanding time management skills, with a track record of making deadlines in a fast-paced environment

Bachelor's Degree, or the equivalent combination of education, professional training, and/or work experience

Exceptional organizational skills, with the ability to multitask and manage competing priorities

3+ years of relevant work experience

Excellent written and verbal communication skills

2+ years of experience working in the Medicare industry

Experience with Jira a plus and or other Project Management tools

Document quality issues and performance measures for management review

Knowledge of HR functional areas (Reporting, Benefits, Talent Acquisition)

Provide information and assist in the feedback and education to staff

Experience with Workday and or ServiceNow preferred

Experience making timely and independent judgment decisions while working in a fast-paced and results-driven environment

Excellent customer service, and quality management skills

Investigates and reports on plant-specific consumer complaints and performs trend analysis. Reports findings to plant Management

Excellent Total Value Benefits Package to include:

Carries out supervisory responsibilities in accordance with the UNITED policies and applicable laws

Strong leadership and organizational skills

Proven ability to coach and manage needs and concerns of multiple associates

Working knowledge of Microsoft Office.

Working knowledge of 21CFR820 and ISO 13485.

2-4 years of relevant work experience.

Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.

Maintain up-to-date DHR/LHR files, including electronic versions.

Prepare sterile disposable product for shipment to sterilizer, including all necessary / ancillary paperwork.

Prior management experience/Must have a demonstrated work history leading highly successful and motivated teams.

Experience in Pharmacy Business Management and/or Healthcare related fields a plus

Lead and coordinate quality assurance testing functions for Pharmacy Business Management across multiple functional areas, including Direct to Consumer platforms.

Should interact and collaborate with Innovation and Engineering team and report on high-level metrics for team management on status and progress.

Define department best practices, oversee personnel management, work with senior leadership on budget and hiring functions.

Participate in project requirement sessions, analyze and build test cases and prepare test plans

Attends regular calibration sessions and calls with management and other sites

Completes projects to support improving the customer's calling experience, including ad hoc reports and trend analysis

Must be able to be flexible and adaptive to changing priorities and job responsibilities

Proficient skill in using Microsoft Office applications, including Excel, Word and Outlook

Strong oral and written communication skills

Ability to meet the physical requirements of frequent sitting and some standing and walking, with bending and reaching as necessary

Strong time-management skills, with the ability to juggle multiple projects and meet

Minimum 6 months experience in quality assurance or operations for a fast-paced digital

Have experience with Airtable, Google Drive, and Microsoft Office 365

Proven communication skills, specifically in relaying complex issues in a digestible,

*Please note that this is a PART-TIME, FREELANCE, REMOTE position.*

Bulk upload electronic publishing files (ePub) to the backend of our app

Medical, Dental and Vision Benefits

Challenging and Rewarding Career Opportunities

401k with partial Company Match

BST has the following disciplines:

BST Systems is an Equal Employment Opportunity Employer

Knowledge of regulatory requirements to include HACCP, GMP's.

Paid time off and paid holidays, plus paid benefits for maternity and parental leaves

Effective written and oral communication skills.

Knowledge of FDA and other applicable regulatory agencies SOP's preferred

Medical, dental, vision, life and AD&D; short- and long-term disability insurance

Retirement savings plan and profit-sharing plan, both with company match

Reviews and revises testing and equipment procedures as needed. Performs equipment and procedure qualifications periodically.

Employ sound technical writing skills involving deviation reports, laboratory investigation reports, etc.

Perform or assist with other Quality Unit assigned activities related to MURR facility responsibilities associated with FDA, NRC, and DOT regulations.

Able to independently perform testing on multiple radiopharmaceutical batches manufactured on a weekly basis.

Assists peers with method development and validation activities.

Contribute to the proper maintenance and organization of the laboratory, laboratory equipment, supplies, records, and samples.

Excellent customer service, and quality management skills

Investigates and reports on plant-specific consumer complaints and performs trend analysis. Reports findings to plant Management

Excellent Total Value Benefits Package to include:

Carries out supervisory responsibilities in accordance with the UNITED policies and applicable laws

Strong leadership and organizational skills

Proven ability to coach and manage needs and concerns of multiple associates

Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.

Highly organized, detail-oriented, capable of multi-tasking, strong interpersonal skills in order to collaborate with individuals in a matrix environment.

Strong knowledge of QC testing of small molecule drugs in a compliant cGMP setting.

10+ years of relevant experience in a cGMP pharmaceutical QC environment, or 8+ years with a Master’s degree.

Experience in a commercial environment highly desirable.

Starts at $199,000 and is commensurate with experience

Six-Sigma/Lean Thinking/Quality Management/Continuous Improvement/Process Engineering experience

Ability to communicate clearly and effectively to a variety of audiences; strong reasoning, and organizational skills

Strong analytical, operational research, root cause, and problem solving skills

Proven ability to motivate teams and manage conflict; ability to provide feedback and develop team

Four year degree or equivalent experience

Americans with Disabilities Act (ADA)

Work closely with the Review Manager and production staff to ensure proper allocation of resources based on deadlines and priorities.

Assist with document review team questions or escalate to Review Manager

Manage work progress and provide feedback to document review team

Technical experience in eDiscovery platforms and tools

Strong technical understanding and/or experience with eDiscovery process, life cycle, and technical issues

Software application proficiency with Microsoft Office, including intermediate Excel skills

Plan and organize own work assignments, as well as carry out tasks from management staff

Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors

Job related technical knowledge necessary to complete the job

Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines

Provide input to the site manager regarding Quality organization and staffing

Assist site manager with resolution of client complaints that are quality-related

Participate in the change management process to assure the products continue to meet customer requirements.

Assist management with the development of quality programs and revisions.

Assist in all supplier qualification endeavors including supplier on site audit and evaluation.

Develop and implement systems to ensure products or produced to meet or exceed customer requirements and expectations.

Assist in defining/developing quality program status indicators, performance measurements and reporting requirements.

This is not a remote position. This position is onsite in West Point, GA.

Knowledge of physical and electronic Document Management workflows and principles

Experience with applicable software (e.g., Learning Management System, electronic Quality Management System, data analytics, etc.)

Process documents in electronic Document Management System

Back-up the Records Management job function as required

Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records

Participates in continual improvement activities within Document Control and GMP Records management