Talent.com
Quality Specialist II
Quality Specialist IIPlanet Pharma • South San Francisco, CA, United States
[error_messages.no_longer_accepting]
Quality Specialist II

Quality Specialist II

Planet Pharma • South San Francisco, CA, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description

Description : The Position

We thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patient's right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

The Opportunity

  • Oversee and execute all required quality activities during the lifecycle of a service provider and / or direct material, including but not limited to :
  • Negotiation and maintenance of Quality Agreements
  • Negotiation and maintenance of Supplier Quality Evaluations
  • Monitoring cGMP compliance, identifying and mitigating quality risks
  • Supporting audits, ensuring audit responsiveness and CAPA implementation
  • Work with suppliers to effectively meet company requirements
  • Approve as Quality Assurance on supplier documents
  • Change management - assess and implement
  • Maintain the Global Approved Supplier List
  • Change management - assess, approve, and implement
  • Discrepancy / investigation - assess, approve, and manage

Qualifications and Skills

  • B.A. or B.S. degree in life sciences
  • Minimum of 6 years' experience in the pharmaceutical industry
  • Minimum of 2 years' experience in a GMP Quality Assurance role
  • Demonstrated ability to apply cGMP concepts and requirements to evaluate using sound judgment and decision making (Hard)
  • Strong problem-solving skills using critical thinking, identifying risk-based resolutions (Soft)
  • Excellent verbal and written communication skills; fluency in oral and written English is a must (Soft)
  • Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives (Soft)
  • Pay Rate Range : $35-44 / hr depending on experience

    Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

    Fraud Alert : Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

    [job_alerts.create_a_job]

    Quality Specialist Ii • South San Francisco, CA, United States

    [internal_linking.related_jobs]
    Quality Control Specialist I - Abstractor

    Quality Control Specialist I - Abstractor

    Public Health Institute • Oakland, CA, United States
    [job_card.full_time] +1
    If you are a current and active PHI employee, do not use this site to apply for positions.The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr. Quality Improvement Specialist

    Sr. Quality Improvement Specialist

    University of California - San Francisco Campus and Health • San Francisco, CA, United States
    [job_card.full_time]
    Quality Improvement Specialist.This position requires onsite work 3 days per week, based on business needs.Reporting to the Director of Adult Quality Improvement (AQI), the Sr.Quality Improvement S...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Inventory Specialist II

    Inventory Specialist II

    Exelixis • Alameda, CA, United States
    [job_card.full_time]
    Completes activities related to the inventory management process in the ERP system.Supports Commercial Supply Chain with a focus on, but not limited to the creation of purchase orders from producti...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Procurement Specialist II

    Procurement Specialist II

    Bio-Rad Laboratories • Hercules, California, United States
    [job_card.full_time]
    Bio-Rad is looking for a Procurement Specialist II.This role is responsible for the procurement of indirect materials and services, issuing purchase orders, creating purchase requisitions, sourcing...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Systems Specialist

    Quality Systems Specialist

    Actalent • San Mateo, CA, US
    [job_card.full_time]
    The Quality Systems Specialist is responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems. This role requires adherence to k...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Laboratory Operations and EHS Specialist II

    Laboratory Operations and EHS Specialist II

    Bonneville Labs, LLC • Berkeley, California, United States, 94710
    [job_card.full_time]
    Bonneville Labs is a flexible coworking and traditional lab space operator and developer optimized for a community of Bio-Doers, emerging biotechnology companies, community partners, and life scien...[show_more]
    [last_updated.last_updated_30]
    Sales Operations Specialist II

    Sales Operations Specialist II

    Columbia Sportswear • Richmond, CA, United States
    [job_card.full_time]
    This is a hybrid role based out of our HQ in Richmond, CA.In-office expectation is 4 days a week.At Mountain Hardwear, we're more than just an outdoor apparel and equipment brand - we're a communit...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Quality Assurance Specialist I

    Quality Assurance Specialist I

    Abacus Service Corporation • San Francisco, CA, US
    [job_card.full_time]
    Duration : 6 months - Onsite - Shift : M / F 2nd shift- 1 : 30- 10pm - Education : High School - Temp To Hire : Yes Basic Function Responsible for auditing the products and processes at various points in t...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Sr Quality Engineer I

    Sr Quality Engineer I

    Gilead Sciences • Foster, California, USA
    [job_card.full_time]
    At Gilead were creating a healthier world for all people.For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Project Controls Specialist III

    Project Controls Specialist III

    Sidara • San Francisco, California, USA
    [job_card.full_time]
    With over 3000 employees throughout the Americas Asia and Europe the firm provides support on projects of varying size and complexity. Together we enhance conventional designs with smarter more resi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr. Manager of Quality and Regulatory

    Sr. Manager of Quality and Regulatory

    Every • San Francisco, California, USA
    [job_card.full_time]
    EVERY is a leading VC-backed food tech ingredient company and market leader using precision fermentation to create animal proteins without the animal for the global food and beverage industry.EVERY...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director of Quality - MedTech, San Jose (Relocation)

    Director of Quality - MedTech, San Jose (Relocation)

    Vantedge Medical • San Francisco, CA, United States
    [job_card.full_time]
    A leading med-tech company is seeking a Director of Quality to oversee quality assurance efforts at their San Jose location. This role involves developing quality control systems, improving supplier...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Quality Control Analytical Sciences

    Senior Director, Quality Control Analytical Sciences

    Apogee Therapeutics • Oakland, CA, US
    [job_card.full_time]
    Senior Director, Quality Control Analytical Sciences.We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee's pipeline.This individ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Safety Specialist II

    Safety Specialist II

    Pinterest • San Francisco, California, USA
    [job_card.full_time]
    Were looking for a strong Safety Specialist to join our Content Operations team - responsible for the enforcement of our content policies under our. This role will be part of our Trust and Safety En...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Improvement Specialist

    Quality Improvement Specialist

    University of California - San Francisco • San Francisco, CA, United States
    [job_card.full_time]
    Quality Improvement Specialist.The Quality Improvement Specialist will provide quantitative and qualitative programmatic and data analysis support to the clinical enterprises and its growing portfo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Staff Specialist I / II

    Staff Specialist I / II

    Government Jobs • San Francisco, CA, US
    [job_card.full_time]
    The Regulatory Development Division works with all levels of the Air District, including staff, management, executives, and Board members in developing and modifying Air District rules to provide e...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Temporary Quality Compliance Specialist

    Temporary Quality Compliance Specialist

    Joulé • Alameda, CA, US
    [job_card.temporary]
    Job Title : Temporary Quality Compliance Specialist Location : Alameda, CA Type : Contract Compensation : up to $70 / hr Contractor Work Model : 100% Onsite Joule is searching for a top-tier Quality Compl...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Technical Quality Specialist

    Technical Quality Specialist

    Figma • San Francisco, California, USA
    [job_card.full_time]
    Figma is growing our team of passionate creatives and builders on a mission to make design accessible to all.Figmas platform helps teams bring ideas to lifewhether youre brainstorming creating a pr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]