qa associate i, process quality inspector.

job summary: Job Description: JOB OBJECTIVE: The Director, Quality Assurance is responsible for the strategic development and execution of quality assurance program including all quality-related decisions. This position reports to the Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This position is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing impact within its field of research.   location: Madison, Wisconsin job type: Permanent salary: $210,000 - 230,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities. 2. Ensures quality metrics comply with best industry standards and practices. 3. Maintains effective quality governance and continually improves governance to meet organizational and compliance needs. 4. Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions. 5. Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet organizational quality standards and government regulations. 6. In collaboration with Clinical team, provides appropriate quality oversight of CROs. 7. Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines. 8. Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities. 9. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met. 10. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc. 11. Interprets and applies quality requirements and provides guidance and training to ensure that Usona and its GxP vendors maintain an ongoing state of compliance. 12. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Usona's Leadership Team. 13. Serves as an escalation point for organizational compliance and quality issues. 14. Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management. 15. Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines. 16. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 17. Embracing and being open to incorporating Usona's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 18. Understands and complies with ethical, legal and regulatory requirements applicable to our business.   qualifications: KEY QUALIFICATIONS: 1. Bachelor's degree, preferably in the life sciences. 2. 15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry. 3. Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities. 4. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice. 5. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. 6. Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization. 7. Strong collaborative, influencing, and interpersonal skills 8. Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management. 9. Ability to prioritize competing activities, manage resources, and budget accordingly. PREFERRED QUALIFICATIONS: 1. Master's Degree 2. Experience/familiarity with regulations related to controlled substances 1. Proficiency with Microsoft Word, Excel, and Outlook. PHYSICAL DEMANDS: 1. Ability to use computer equipment.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: JOB OBJECTIVE: The Manager, Quality Assurance - API is responsible for providing the direction and leadership for quality assurance processes for product quality and GMP compliance of contract manufactured Active Pharmaceutical Ingredient (API) products.   location: Madison, Wisconsin job type: Permanent salary: $110,000 - 120,000 per year work hours: 9 to 5 education: Bachelors   responsibilities: CORE DUTIES: 1. Manage QA staff involved in key processes such as CAPA, Non conformances, Change Control, Audit, Training, and Document Control & and Records related to the manufacture of API products. 2. Design, develop, and manage key quality system processes to ensure compliance with the requirements for API products. 3. Work with QA leadership to improve quality system processes and overall quality and regulatory activities. 4. Participate in both internal and external audits; play an active role in maintaining an inspection ready state. 5. Represent Promega in discussions/interactions with regulatory bodies, partners, vendors, or customers. 6. Actively coach, mentor and develop team members and leaders within the department. 7. Lead and support cross-departmental, corporate, and team projects and initiatives. 8. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 9. Embracing and being open to incorporating 6 Emotional & Social Intelligence (ESI) core principles in daily work. 10. Understands and complies with ethical, legal and regulatory requirements applicable to our business. KEY QUALIFICATIONS: 1. University degree (B.S. or M.S.) in a biological or chemical science or other relevant field. 2. Minimum of 10 years related experience in quality control, quality assurance, product support, or manufacturing. 3. Working knowledge of quality standards governing API products including 21 CFR 210 & 211 and ICH Q7. 4. Ability to understand basic statistical concepts and analytical data. 5. Ability to communicate (in written and oral forms) in a concise, clear, and accurate manner. 6. Proven ability to work constructively with a broad range of people, backgrounds, and functions. 7. Ability to perform analysis of complex problems or data requiring in-depth evaluation of various factors. 8. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. 9. Proficient with electronic tools including Microsoft Office applications and eQMS programs.   qualifications: PREFERRED QUALIFICATIONS: 1. Technical knowledge or experience in scientific areas specifically applicable to small molecule drug manufacturing. 2. Previous experience managing FDA inspections. PHYSICAL DEMANDS: 1. Ability to remain stationary and use a computer for extended periods of time.   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Technical Services, and others. JOB OBJECTIVE: Through their specified review, approval, and planning roles, QA Scientists apply their technical and quality system knowledge to assure internal and external customers that:   location: Madison, Wisconsin job type: Permanent salary: $97,000 - 97,500 per year work hours: 9 to 5 education: Bachelors   responsibilities: 1. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality. 2. Product and Process Changes and Quarantine disposition plans are implemented according to established procedures. 3. Technical literature (PPIs, labels, Technical Bulletins etc) are accurate and consistent. 4. Product performance claims and release criteria are based on objective data analysis. CORE DUTIES: Note that the emphasis placed on the essential duties listed here will vary by individual, depending on the focus and balance of that person's specific responsibilities. 1. Audit, data review, and approve product batch records for the next manufacturing step or availability in inventory. 2. Review and approve Manufacturing and Quality Control Protocols for catalog and custom products. 3. Review and approve product labels. 4. Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing, Regulatory Affairs and R&D staff. This includes approval of study design, data review, and change approval. 5. Review and approval of Technical Bulletins and Technical Manuals (performance and application claim accuracy and validity), including final release for publication. 6. Review and approve Promega Product Information (PPI) specification sheets and Certificates of Analysis; initiation, completion and issuance of these documents as required for custom products and some catalog products. 7. Assess the scope and inventory impact of nonconforming product situations; approving disposition plans of inventory product under quarantine; assisting in the disposition planning for nonconforming product in branch inventories. 8. Assist in the preparation, review and approval of design control documents. 9. Initiate, implement, review and/or approve Product and Process Change Plans. 10. Review, implement, and/or participate in Corrective and Preventive Action plans. 11. Review, implement, and participate in product and process validation planning. 12. Review, implement, and participate in complaint investigation planning. 13. Participate in process mapping and SOP development as directed. 14. Write SOPs as assigned. 15. Participate in team meetings to resolve planning and technical issues. Propose constructive solutions to existing problems. 16. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk. 17. Consider basic regulatory requirements in product or process issues. 18. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 19. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 20. Understand and comply with ethical, legal and regulatory requirements applicable to our business. OCCASIONAL DUTIES: 1. Organize, facilitate, or lead meetings to discuss review findings and planning issues. 2. Represent Promega in support of technical sales at national and international trade shows and exhibitions, or attend relevant scientific meetings as requested. 3. Contact customers directly about quality issues or questions as directed. 4. Organize and implement training programs in areas of expertise and experience. 5. Participate in continuous improvement projects.   qualifications: KEY QUALIFICATIONS: 1. B.S. degree with a minimum of 7 years work experience in a relevant industry with quality control, quality assurance, or manufacturing responsibilities. 2. Working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. 3. Proficiency with basic word processing and spreadsheet software programs. 4. Ability to apply basic statistical concepts to analytical data, process validation, and Quality Assurance activities. 5. A demonstrable track record of process improvement and effective procedure writing and revision. 6. Able to develop concise, clear and accurate written communication. 7. Proven ability to work constructively with a broad range of people. PREFERRED QUALIFICATIONS: 1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications. 2. Work experience in Quality Assurance from a regulated industry. PHYSICAL DEMANDS: 1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation. 2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves). 3. Ability to use computers in an interactive manner for extended periods of time.   skills: Biology, Chemistry, GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.