Overview
Quality and Safety Oversight Specialist V, Clinical Quality Oversight Jobs in Walnut Creek, CA at Kaiser Permanente
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare!
What can Adare offer you?
Medical/dental/vision/life – low employee premiums
401k with a highly competitive match
Generous PTO, including floating holidays
Career growth and internal opportunities
Tuition reimbursement
Relocation assistance
Performance-based bonus
Employee Recognition Programs
We are seeking to hire a Specialist I, Manufacturing Quality to join our Operations team…
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The Specialist I, Manufacturing Quality is a critical member of the Operations team, responsible for supporting documentation and procedural activities associated with non-conformance investigation reports and actions that come out of the reports. This includes participating in investigation, analysis, and writing of minor non-conformances and the associated reports.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
Provide documentation services, mainly minor OOS Investigations, to the Manufacturing department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.
Work with Sr Specialist onRoot Cause Analysis and proper investigations for minor OOS and Deviation cases.
Support all Quality Systems for the Manufacturing Department, including CAPA, Change Control, NCIR tracking/trending.
Review, update and approve Standard Operating Procedures (SOPs) and other official documents.
Support all Continuous Improvement efforts within the department.
Support monitoring and reporting department metrics on a continual basis.
Provide assistance to execute, track and analyze assigned projects. Help identify any project dependencies and critical paths.
Effectively communicate and manage project expectations and success criteria to project sponsors, team members, vendors and other stakeholders in a clear and concise manner throughout the project lifecycle.
Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines.
Support Manufacturing Manager in reducing compliance risk by aiding in performing internal audits and developing action items to correct risks.
Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
Works effectively under deadlines.
Respects policies, procedures and regulations in force in the company.
Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
REQUIRED SKILLS AND QUALIFICATIONS
Associates degree with 3 years of experience in manufacturing or HS Diploma with 5 years of experience in manufacturing.
Technical writing and/or procedure development, preferred.
Knowledge of Oral Solid Dose / Tablet manufacturing techniques a plus
FDA or other regulated environment a plus
Proficient with Microsoft Office (Excel, Word, PowerPoint).
Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
Demonstrated ability to write logically and consistently
Assertive Influencing & Collaboration/Teaming Skills
Strong decision making and problem solving skills
Excellent interpersonal written and oral communication skills
Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
Exceptional attention to detail and excellent organizational skills
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES
Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there’s no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can’t quickly verify the identity of the poster.Show more
Title: Quality and Safety Oversight Specialist V, Clinical Quality Oversight
Company: Kaiser Permanente
Location: Walnut Creek, CA
