Location: Red Wood City
Shift 5:30AM - 2 M-F
Duration: 1 year
BR : ***
Interview 1st round with manager and 2nd round onsite
Overview & Position Details
Job Title: Quality Assurance Specialist (Manager is also open to evaluating Senior QA Specialist candidates)
Location: Redwood City, CA (On-site; Manufacturing Supply Site)
Contract Type: 1-Year Contract (Direct headcount replacement; no option for full-time conversion)
Work Schedule / Setting: Shift coverage (facility operates 24/5 across day, swing, and night shifts). Production support setting (~80% on the manufacturing floor, ~20% office/workstation)
Special PPE Requirement: Must be willing and able to wear a PAPR (Powered Air-Purifying Respirator) suit and breathing apparatus for extended periods while in the manufacturing suite (approx. 80% of the day)
Target Start Date: As soon as possible (targeting mid-December NEO or early January)
Key Role Responsibilities (What the Role Entails)
On-the-Floor (OTF) QA Support: Act as the dedicated QA presence on the manufacturing floor, answering compliance questions and guiding 7 8 manufacturing technicians per shift.
Batch Record Review & Guidance: Guide technicians on GDP/GMP batch record compliance, assist with appropriate comments/entries, and perform final review and approval of executed batch records.
Material & Product Release: Review and approve the release of incoming raw materials as well as the finished product (functional excipient powder produced via spray drying for MDI inhalers).
Quality & Compliance Oversight: Ensure adherence to standard operating procedures (SOPs) and cGMP regulations in real-time production.
Candidate Requirements & Qualifications (What is Needed)
Education: Bachelor s degree required (per job description).
GMP / Industry Experience:
Hands-on cGMP experience within pharmaceutical or biotech manufacturing.
Background in Quality Assurance (QA) in a manufacturing plant environment is strongly preferred.
Technical & Operational Readiness:
Familiarity with executed batch record review and raw material/finished product disposition.
Ability and comfort working in a manufacturing cleanroom suite wearing a PAPR suit for up to ~80% of the shift.
Key Behavioral & Soft Skills:
Attention to Detail: Critical for meticulous batch record auditing, data integrity, and compliance checks.
Effective Communication: Ability to collaborate, guide, and communicate clearly and constructively with manufacturing operators, shift leads, and quality teams.
Adaptability: Comfortable working on the production floor in a dynamic 24/5 manufacturing schedule.
Responsible for QA activities that directly support execution of the process both within the Process Execution Team (PET)
and in assigned areas outside of the PETS. These activities may include but are not limited to: batch release, change control
and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution
center management, and regulatory interactions.
Major Responsibilities
Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment
and facility to which the position is aligned:
Batch Records and associated documentation
Product and Component Release transactions in SAP
Quality Investigations (Deviations, Product Complaints)
Standard Operating Procedures
Collaborates with other Quality professionals across the organization to ensure consistent application and execution of key quality systems
Executes QA processes including batch record review, product and material disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
Collaborates with other PET/assigned area members and support process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
Stays abreast of evolving regulatory compliance practices
Performs selected quality assurance activities, dependent upon assigned area, including the following:
Reads, understands, and follows SOP s and complies with cGMP s
Writes new standard operating procedures or revises existing documentation utilizing document management systems
Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
Supports the issuance and reconciliation of GMP documentation
Electronic system usage with tools such as Veeva EQV, GQCLIMS, and SAP
Reviews documented information from their functional area, reports abnormalities
Assists supervisor by assembling metrics as requested for their functional area.
Provides task-oriented training to Specialists.
Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
Represents QA on site committees such as SHE, etc.
Proposes and implements process and other efficiencies as approved by manager.
QA Specialist
At this level the incumbent is not necessarily performing all the major responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.