QA Specialist, Quality Operations

Role Summary

The QA Specialist, Quality Operations (QAO) role is an individual contributor that guides and supports the GMP material receipt and manufacturing process on the floor by providing Quality Assurance oversight. The position will be focused on day-to-day support of manufacturing operations, and quality review and disposition of documents associated with raw materials and manufactured products.

Responsibilities

• Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures in support of disposition of manufactured product. Document, manage and support issue resolution associated with batch review.
• Perform inspection and release of incoming raw materials according to appropriate material specifications and standard operating procedures.
• Perform Quality Assurance activities to support Manufacturing operations, including but not limited to product label issuance/reconciliation, batch record issuance, Starting Material (i.e. Cell Banks) Receipt, Release and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management.
• Perform Product Complaint Investigations to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate Quality Deviation and perform robust investigation to determine root cause and identify/implement related Corrective and Preventative Actions.
• Initiate and Own Quality Change Control, complete associated implementation task assignments and provide supporting documentation for completion of change records.
• Perform Manufacturing Floor Observations (including Practice vs. Procedures, Aseptic Technique and Media Fill Observations) to ensure inspection readiness.
• Identify Continuous Improvement Activities and implement changes to enhance the overall Quality Systems, Procedures and Oversight of GMP Operations.
• Support both Internal and External Compliance/Regulatory Audits.
• Maintain compliance with all assigned training requirements and train others as assigned.
• Create, Draft and/or revise SOPs, Work Instructions, and other controlled document types, as assigned.
• Collaborate in cross-functional team meetings to resolve quality issues.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor‚Äôs degree in an engineering, biological science, chemistry, or related science field required.
• 5+ years of experience in the pharmaceutical / biopharmaceutical industry required.
• Experience of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing required.
• Strong understanding of and experience working with quality management systems required.
• 2+ years of direct experience in Quality Assurance / Quality Control preferred.

Knowledge, Skills, & Abilities

• Strong verbal, written, and interpersonal communication skills.
• Proficiency in computer use and Microsoft Office applications.
• Proven ability to work independently to analyze and resolve issues that impact quality.
• Attention to detail with strong analytical and problem solving skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Experience in supporting both internal and external regulatory inspections (i.e FDA, EU).

Education

• As listed in Qualifications

Additional Requirements

• This position works on site.
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval.
• Must be able to work flexible hours to support manufacturing needs, sometimes including weekends and holidays.
• Will occasionally be exposed to excessive noise, hazards, extreme temperatures, and outdoor work.
• Must be able to gown under clean room conditions.
• Will frequently perform indoor work by sitting at desk operating computer.
• Exposure to onsite in-lab environment.
• May occasionally reach outward, above shoulder, lift/carry 20 lbs or less, and push/pull 12 lbs or less.
• Will occasionally stand, walk, bend, travel to other facilities.