Quality Assurance Specialist

Synectics Inc.; Redwood City (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Healthcare Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

Synectics Inc. is seeking an on-floor QA support professional to guide technicians, ensure GDP/GMP batch record compliance, and approve material and product releases.

The role focuses on real-time cGMP adherence, SOP execution, and cross-functional QA collaboration. You will review batch records, participate in CAPA and change control, and ensure final disposition of materials and products while staying current with regulatory requirements.

Qualifications

• Bachelor's degree required.
• Hands-on cGMP pharma experience preferred.
• Ability to work on manufacturing floor in PPE (PAPR).
• Strong attention to detail and data integrity.

Responsibilities

• Act as QA presence on the manufacturing floor for 7-8 technicians per shift.
• Review and approve batch records and GMP documentation in SAP and related systems.
• Release incoming materials and finished products per GDP/GMP.
• Ensure SOPs and cGMP compliance in real-time production.
• Collaborate with QA and PET to improve processes and risk assessments.

Skills

Attention to detail

Effective communication

Adaptability

Education

Bachelor's degree

Tools

SAP

Veeva EQV

GQCLIMS

Job description

Description

• 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.
• 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.
• 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.
• 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.

Qualifications

• 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.
• 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)
• Shift 5:30AM - 2 M-F

California Fair Chance Act

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.