Manager, Quality Assurance

Manager, Quality Assurance

W2 Contract-to-Hire

Pay Rate: $60 - $65 per hour

Location: San Carlos, CA - Hybrid Role

Job Summary:

We are seeking a part time Quality Assurance Manager to maintain our Quality Management System and continue to improve upon it. We're looking for an individual with direct pharmaceutical manufacturing QA experience to continue to grow the quality system as the company grows. The individual must have experience in a pharmaceutical manufacturing environment and must have had direct interaction with auditors and inspectors during FDA and other regulatory or quality audits.

Duties and Responsibilities:

• Support the maintenance and continuous improvement of the company's Quality Management System, including policies, procedures, risk assessments and other documents in alignment with global health authority regulations (FDA, EMA, ICH, etc.)
• Provide QA review and approval of validation protocols/reports to ensure compliance with current regulatory guidance and industry practices.
• Manage and perform all Document Control activities, including initiating Document Change Orders, preparing documents for approvals, tracking DCOs, and maintaining document listings.
• Manage company Calibration and Preventative Maintenance activities. Notify departments of upcoming Cal/PM's due, track Cal/PM's, interact with calibration vendors.
• Manage company training program, assuring that all employee training is up-to-date and documented.
• Participate in inspection and audit readiness activities, including documentation preparation and coordination for internal audits, customer audits, and regulatory inspections.
• Perform gap analyses and internal audits.
• Participate in external audits as QA representative.
• Support internal QA batch review and release processes to ensure compliance with the Company's QMS and applicable regulations.
• Assist in tracking and maintaining quality metrics and performance indicators.
• Maintain External Standards database and copies (FDA, ICH, USP, ISO, etc.)
• Prepare Quality objectives and perform annual Management Reviews.
• Collaborate with cross-functional teams to achieve quality and compliance objectives.
• Perform other duties as assigned to support Quality Assurance initiatives.
• Other duties as assigned

Requirements and Qualifications:

• Minimum Bachelor's degree (BS/ BA) in a technical discipline (Engineering, Chemistry, Biochemistry, etc.). A minimum of five to eight (5 - 8) years of GxP and Quality Assurance experience in the pharmaceutical industry is required.
• Must have experience in developing, maintaining, and representing Quality Management Systems. Must have an understanding of general statistical principles and methods.
• Must have direct experience with internal, client, Notified Body, and FDA audits, including direct interactions with auditors.
• Must be organized and detail-oriented. Must be able to manage time efficiently. Must be able to work effectively with staff members of different backgrounds. Must have excellent written skills, including proper grammar for document creation. Must be able to follow verbal instructions and written protocols.
• Must be able to communicate any issue or problem with Supervisor and senior staff in a timely manner.
• To perform this job successfully, candidate must have a working knowledge of Microsoft Office Suite (Word and Excel) and basic internet tasks. Experience with Minitab or similar statistical software is a plus.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.