QA Specialist - Drug Products in Fremont, CA at Apex Life Sciences

Date Posted: 11/2/2018

Job Snapshot

Job Description


Duties

  • Works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including aseptic knowledge, drug product processing, visual inspection, syringe and vial filling, labeling and packaging, batch record review, critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, new product introduction/product transfer, external quality and laboratories
  • Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements
  • Provides guidance and mentorship to junior staff regarding decision making processes and process expertise with high-level quality oversight to ensure compliance with cGMPs, regulatory, industry, and corporate requirements
  • Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation
  • Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business including the on-going training of junior team members
  • Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations
  • Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone
  • Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations
  • Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business
  • Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities
  • Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures
  • Analyzes and reports findings to appropriate departments. Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFIs Quality Systems. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements. Will serve as Subject Matter Expert for internal or external matters
  • Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies
  • Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations

Qualifications:

  • Bachelors degree, from an accredited institution, in Microbiology, Biology, Chemistry, or closely related degree with these core courses as the foundation required
  • 5-7 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas
  • Excellent attention to detail, i.e. labeled drug product
  • Project management experience
  • Strong independent judgment and decision making abilities required
  • Strong knowledge of relevant regulatory guidance
  • Demonstrated problem-detection and problem-resolution skills required
  • Strong conflict resolution and negotiation skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects
  • Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes
  • Must possess excellent verbal and written communication skills; good interpersonal skills. Mentoring experience required
  • Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. 

***For immediate consideration, please email your updated resume to bfreeman@apexlifesciences.com with 'QA Specialist CA' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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