QA Specialist I

Summary:

Responsible for providing comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable Health Authorities. Supports one or more of the following areas: manufacturing, testing, process validation, disposition and quality systems by applying a high degree of technical background to resolve issues within defined parameters and occasional deviation from standard practices. Makes recommendations to management on operating policies and procedures. Builds productive internal working relationships and limited external work relationships.

Ensures adherence to and compliance with established company quality policies, practices, SOP’s, federal regulations. Ensures that Biocept’s product(s) consistently meets our customer and regulatory requirements, by proposing process improvements and/or participating in strategic initiatives.

May provide direction to other members of the team to schedule and oversee routine activities and initiatives of moderate complexity.

Job Responsibilities

Essential

• Supports department to meet corporate goals, global business process initiatives and department objectives
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Collaborate with other departments to address issues and meet deadlines
• Provide guidance and coaching in the application of cGMP throughout Quality
• Support CAP/Regulatory inspection activities
• Participate in internal audits
• Train staff as needed
• Write and revise SOPs as required, including Change Control activities.
• Support monitoring and analyzing of business process performance measures
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).Create data and slides of key performance Indicators for management review. Present slides as needed.
• Manage filing of deviations and summary reports along with the CAPA system.
• Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.

CAPA

• Support the timely review and closure of CAPAs as assigned and per defined procedures. Direct close attention to monitoring the status of open CAPAs to ensure due dates are met and that CAPA owners are providing updates as per defined procedures.
• Collaborate as needed with SMEs to foster compliance with CAPA program and procedures.
• Provide support to CAPA training development as required.
• Under direction of manager/supervisor, contribute to the development and implementation of CAPA effectiveness monitoring. Support the review of CAPAs for effectiveness and compliance.
• Participate in Quality Systems and Continuous Improvement activities as assigned.

Batch Production Record Review

• Provide on-site QA presence within the manufacturing facilities.
• Perform QA oversight and reviews, as required, of process documentation associated with product lots.
• Identify product-impacting deviations associated with the manufacturing process as soon as they occur and ensure prompt documentation and communication to QA Management.
• Assess manufacturing facility, critical manufacturing activities, utilities, and operational support systems for compliance with approved SOPs and cGMP.
• Evaluate and review Manufacturing Documentation, Failure Investigations, and Testing data associated with production.
• Perform batch record and batch report review and approval.
• Participate in cross-functional team meetings for such events as process improvement and/or operational activities as a QA representative.
• Execute QC tests as needed.

Batch Disposition

• Review Batch History Records (BHR), as needed
• Compile and verify all documents associated with the batch
• Interact with multiple departments to coordinate and facilitate batch disposition activities and achieve batch disposition standard lead times.
• Prepare, review, and approve batches for disposition
• Manage Quality System for Release process, such as Discrepancies, change control
• Communicate batch disposition pending issues to site Management
• Compile regulatory filing documentation as needed
• Assess product complaint investigation action items, as applicable

Process Validation

• Provide quality oversight to ensure that non-GMP process validation protocol, report and supporting deliverables are compliant with Biocept quality requirements and procedures.
• Review and approve non-GMP validation project plans, process validation protocols and reports, validation protocol deviations, and annual process monitoring protocols and reports.
• Author and own non-GMP Process Validation documents to ensure Quality oversight, as applicable
• Provide assessments for change orders on direct impact to process to ensure the validated state is maintained and identify required Process Validation.
• Assist or interact with regulatory agencies as necessary. Must be able to present and defend GMP documentation associated with quality practices.

Discrepancy Management

• Sponsoring and/or performing quality investigations of significant manufacturing deviations, GMP issues, system issues and non-conforming materials.
• Providing Quality Assurance support to resolve raw material, in-process material, final product, environmental, and system issues.
• Defining and directing investigation efforts to maximize efficiency and timely resolution, overseeing the assembly, review and approval of scientific and technical reports in support of investigations.
• Performing and documenting discrepancy trend and/or continual improvement analysis with generation or approval of associated reports.
• Reviewing final evaluations and written summaries that assess product quality impact consistent with Roche and regulatory standards, recommending material dispositions, and identifying potential corrective actions and tracking to ensure completion.
• Chairing/participating in routine and non-routine meetings and projects with affected groups to communicate and resolve system and quality issues tied to investigations or improvement projects.
• Applying scientific/technical expertise to the evaluation of raw materials/components and their suppliers by participating in internal and vendor audits, and provide audit teams with historical information on investigations.
• Assisting in maintaining assembled investigation packages in QA for reference and presentation/review during regulatory agency inspections.

Job Requirements

Education and Experience

• AA degree and 7+ years related experience
• BA degree and 0-2 years experience (Biology or Biochemistry preferred) or Equivalent
• Minimum 5 years Biotech experience
• Minimum 3 years experience in Quality Assurance

Knowledge, Skills, and Abilities (May not apply to all supplementary areas)

• Familiarity of computer-based systems
• Excellent communication skills, verbal and written
• Demonstrate strong verbal and written communication to effectively perform assigned duties.
• Works under general supervision.
• Manager provides work priorities, timelines and resources. Instructions given on new lines of work or special assignments.
• The ability to work in a team environment is critical.
• This position requires the ability to understand technical aspects of Biotech manufacturing operations.
• Must have a general understanding of clean room practices, equipment and utility IQ/OQ/PQ/PV and change control practices/strategies.
• Must have a basic understanding of engineering and scientific principles, drawings and the ability to review QC analytical data.
• Must understand Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
• Strong knowledge of Good Manufacturing Practices, Standard Operating Procedures, Quality Systems, and general compliance principles.

Work Environment/Physical Demands/Safety Considerations

• Works in office environment.
• On occasion may work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
• May be exposed to hazardous materials and chemicals.