Associate Director Quality Control Jobs in San Mateo, California

•Management of GCP QA audit initiatives, quality systems, and provision of internal/clinical study team support

•Requires at least 8 years of prior managerial experience

•Bachelor's degree in a scientific field or equivalent qualification

Key areas of responsibility encompass:

•This position holds a direct reporting line to the Vice President of Quality

•Ensures proper and timely escalation of quality matters, including potential misconduct or significant deviations in projects/products

Previous working experience in the lab, sample management, aseptic techniques, and cell culture activities are highly recommended.

Executes QC sample management activities, which include receipt, inventory sample entry, sample distribution, sample label creation, sample coordination/shipment preparation, and disposal.

Performs routine maintenance of laboratory reagents/materials orders and inventory management.

Should be able to manage the workload, meet deadlines, be eager to learn new techniques, and demonstrate good organizational skills.

Basic understanding of Good Laboratory Practices (GLP) with strict adherence to cGMP requirements is essential.

Dependable, able to learn new skills rapidly, and able to work well within the team.

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Other projects or responsibilities as may be required.

1-3 years of previous experience in a laboratory setting

Familiarity with basic lab equipment and knowledge of lab safety protocols

Excellent organization, communication, and problem solving skills

Preferred Qualifications – Education and Experience

Other projects or responsibilities as may be required.

1-3 years of previous experience in a laboratory setting

Familiarity with basic lab equipment and knowledge of lab safety protocols

Excellent organization, communication, and problem solving skills

Experience with some of the following applications: flow cytometry, western blotting, Immunoprecipitation, bioassays, ELISA and IHC/ICC

Experience using basic laboratory equipment; knowledge of safe laboratory procedures.

Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

Six (6) years of relevant experience or a Bachelor's degree in a related field plus two (2) years of related/relevant experience.

Working knowledge of research function. Knowledge of test methods used to test cell therapy products or similar characterization assays.

Skills to communicate complex information in a clear and concise manner both verbally and in writing.

Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.

Responsible for the inventory management of media and reagents

Experience in biotechnology with cGMP regulations, practices and requirements pertaining to the manufacturing and testing of biopharmaceuticals

May participate in and/or support method qualifications, validations, and transfers

1+ years’ experience with mammalian cell culture and bioassay analytical methods

1+ years of biopharmaceutical experience

Demonstrated in-depth knowledge of laboratory equipment and operations, including working with hazardous compounds and chemicals

Previous experience in the use of all common analytical laboratory instrumentation, i.e., flow cytometers is preferred.

Effective analytical and problem-solving skills.

Knowledge of general laboratory safety.

Effective written and oral communication skills.

Assists with analyzing and solves problems in Production and Quality Control for existing products, also relating to customer complaints.

Maintain inventories of reference materials or other assay standards. Prepares supplies and reagents and assists with laboratory maintenance as needed.

Notate any found discrepancies from the product description documentation and promptly report them to Supervisor and Shift Manager

Learn and maintain a thorough knowledge of procedures required by various customers, products, airlines, and destinations

Learn and maintain a thorough knowledge of cargo loading devices (ex. LD3, AKE, PMC, etc.)

Report any Compliance issues to the Shift Manager in a timely manner

Quickly report any Compliance issues to the Shift Manager

Other duties as assigned by the Facility Manager, Shift Manager, and/or Shift Supervisor

Preferred Qualifications – Education and Experience

Other projects or responsibilities as may be required.

BS with> 5 years of laboratory experience; minimum 3 years performing flow cytometry assays (> 4 color)

Proven track record of knowledge of immunological techniques and ability to troubleshoot with minimal supervision

Excellent organization, communication, documentation and problem-solving skills

Industry experience > 3 years ideally with product development or manufacturing experience

Knowledge of ICH method qualification guidelines and GDP required

Workup, review, and delivery of method feasibility and method qualification results

Provide written protocols for method qualifications and written method qualification reports

Bachelor's Degree in Biology, Biochemistry, Chemistry, or a related science required with 3-5 years of relevant experience

Proficient knowledge of United States Pharmacopeia standards in relation to Microbiological testing

Computer skills (Database software, Microsoft Office Suite)

3+ years experience in instructional coaching, adult learning and data management/analysis.

Experience with learning management systems, Google Suite, Salesforce and other CRMs.

Maintains current knowledge of coaching and learning trends and research, reporting findings and making recommendations to the National Program team.

Prior experience coaching adults, staff and building and growing professional relationships with a diverse group of internal and external stakeholders.

Experience leading professional development trainings or workshops for adults with an equity centered lens.

Experience building relationships with educators and school or district administrators.

Excellent interpersonal skills with ability to work effectively with individuals at all levels (i.e. Management, CM, Development, etc.)

Apply software testing skills to ensure high quality software in multiple domains

Experience in developing comprehensive and accurate test designs and plans

Experience designing and executing black, white and gray box test conditions

Strong verbal and written communication skills

Experience with a comprehensive set of testing types, including unit, regression, integration, freestyle, and acceptance testing

Responsible for oversight of contract QC laboratories including routine performance management and participating in audits to ensure sustained quality analytical deliverables.

Must have knowledge of cGMPs and biotechnology-derived product relations. Previous contract manufacturing facility experience is preferred.

Responsible for planning, scheduling and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of KBI.

Responsible for initiation and overseeing projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement.

Responsible for leadership of method validation of transferred methods.

Responsible for collaborating with cross-functional teams as the Quality Control Subject Matter Expert.

Must possess strong organization skills

Perform documented methods required for finished product quality testing

Review manufacturing documentation for process deviations

Communicate analyzed results in detailed written reports.

Maintain archive of control sample inventory required for product testing

Maintain accurate and detailed records

Elixir Operations; Elixir Technology Services

For more detailed information around city/state required notices, click here to access a list of disclosures.

New Jersey Law Against Discrimination (LAD)

Determine if incoming orders match criteria as stated on the purchase order, and if a problem exists, inform the QC Manager.

Perform miscellaneous duties as assigned by the QC Manager.

Inspect incoming orders to ensure quality of merchandise meets established standards.

Attach scanned labels to corresponding cases.

Resolve any discrepancies that might exist between quantities received and quantity stated on the vendor ASN.

Ability to talk and hear

At least 3 years of management experience required

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

Oversee and conduct cGMP, ICH, and ISO stability programs to comply with regulatory requirements

Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees

Master's Degree in Chemistry or Chemical Engineering with a minimum of 5 years work experience in GMP manufacturing required or

Bachelor's Degree in Chemistry or Chemical Engineering with a minimum of 8 years work experience in GMP manufacturing required

Maintain compliance with applicable ICH, GLP, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Record data per GxP requirements. Provide peer review of documentation as needed.

At least 1 year of experience in GMP pharmaceutical environment.

Senior Manager Quality Control, Biologics CMC

Perform sampling, testing and release of raw materials and in process testing.

Perform testing as per current approved test method and maintain accurate laboratory records and adhere to cGMP/GDP expectations.

Expert knowledge of regulations, and experience with interpretation and application

Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead/supervise a large team of employees

May participate in management of budgets

Excellent written and verbal communication, presentation, and facilitation skills· Strong negotiation skills and significant experience in interacting with regulatory authorities

Expert knowledge of FDA and other regulatory requirements (e.g. Eudralex, PICs, WHO) for pharmaceutical manufacturing

Implement policies to ensure ongoing compliance of regulatory requirements

PhD with 10 years’ experience in the sciences or equivalent education and work history.

Strong leadership skills with experience in managing diverse groups/teams

Manage assigned staff in accordance with company policies and procedures

Strong background in analytical chemistry with experience in cGMP

Coordinate improvement within the Quality Control department to optimize methods and processes

Establish metrics and KPIs to drive OpEx performance and operational efficiencies within the QC group

Experience with electronic Quality Management Systems (eQMS) is desirable

10+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GMP Compliance

Strong knowledge in international regulations and guidelines (EU / FDA regulations, ICH etc.)

Work collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills

Excellent organizational, communication, and interpersonal skills

Excellent documentation skills, e.g., reports, presentations, etc.

Communicate effectively with cross functional stakeholders and quickly find solutions.

Organize and /or provide advanced training to batch production and quality control team to ensure high manufacturing efficiency and quality standard

Work closely with R&D and setup process to facilitate product troubleshooting and redevelopment transfer from QC to PE to R&D.

A minimum of 2 years of management experience including leading, motivating, and developing technical staff.

Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.

Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.

Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).

Develops, revises and reviews investigations, SOPs, qualification/validation protocols and reports

Manage QC files and Environmental Monitoring electronic databases.

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Generous paid time off, including:

Strong execution capability, time-management skills, and multi-tasking; ability to quickly shift priorities in support of production needs

Executes additional duties and responsibilities as assigned

Minimum 2 years of work experience in manufacturing

Every employee is offered lean manufacturing and 5s training

We offer quarterly production bonuses

Great benefits including 10 days paid time off, insurance, 401k, and more!

Understanding of scientific principles, ability to communicate with peers and management.

Participates in the execution of method/material qualification and analytical improvement projects.

3+ years of relevant experience (B.S. Degree), 6+ years of relevant experience (A.S. degree)

Solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g. strong test method/scientific base).

Provides timely review of data and documentation generated for or by QC.

Ability to perform color differentiation testing.

Excellent attention to detail, strong project and time management skills and the ability to manage multiple priorities with aggressive timelines.

Equivalent combination of education and experience may be accepted in lieu of any required degree.

Minimum of 2 years of experience conducting quality control testing on biotech products

Prior experience in GxP regulations and quality systems is strongly preferred.

Good analytical skills for diagnosing problems, identifying potential solutions

Prior experience working with ERP and laboratory LIMS systems. Experience with NetSuite preferred.

• Strong project management skills, with the ability to manage multiple projects and initiatives simultaneously.

• Collaborate with internal team members in Supply Chain Management, Production, and Merchandising.

• Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.

• Conduct regular audits of manufacturing partners and implement corrective actions to address quality issues.

• Perform other duties as assigned.

• GIA Graduate Diamond Diploma required.

Excellent verbal and written communication skills with the ability to train staff.

Excellent organizational skills and attention to detail.

Strong analytical and problem-solving skills.

Strong supervisory and leadership skills.

15-20 years’ relevant work experience, with 5+ years of supervisory experience.

Thorough understanding of quality control standards and methodologies.