Position Title: Quality Assurance Senior Associate
Work Location: Holly Springs, NC 27540
Assignment Duration: 12 Months
Work Schedule: Shifting schedule including 2nd and 3rd shifts
Work Arrangement: Fully Onsite
Position Summary:

• The Organization North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations.
• This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance.

Key Responsibilities:

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the our organization Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and our organization requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

 Qualification & Experience:

• Strong cGMP and GDP behaviors
• Experience in biotechnology, Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.00/hr.