QA Specialist Drug Product
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QA Specialist Drug Product to be part of our client’ s team in Fremont. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
QA Specialist Drug Product:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
- Authorized to suspend any operation when the situation warrants.
- Provides guidance and control directives regarding remediation activities required to continue production.
- Required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.
- 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 BIFI’ s 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
Summary of Qualifications:
- Requires a Bachelor’ s degree, from an accredited institution, in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation).
- Five (5) to seven (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.
- Must possess excellent verbal and written communication skills; good interpersonal skills.
- Mentoring experience required.
- May require the incumbent to exert some physical effort. 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.
- Must be able to read and see clearly.
- Employees assigned to Visual Inspection Drug Product will be required to participate and have acceptable results from vision testing including color-blindness.
- Frequently required to exercise judgment and make decisions.
- Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.