Quality Assurance Senior Associate #26-27458

US Tech Solutions; Holly Springs (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

US Tech Solutions is seeking a Sr. Associate Plant Quality Assurance (PQA) on-the-floor to partner with plant manufacturing and support groups for bulk drug substance production and new product introductions.

You will drive real-time decision making to ensure GMP quality requirements, providing coaching and direction for manufacturing events, deviations, and quality systems. This role emphasizes collaboration between Manufacturing and Quality staff, overseeing deviations, CAPAs, and change

Formación

• Must have strong knowledge of cGMP and GDP in a biotech manufacturing setting.
• Experience working in regulated environments with Quality Assurance oversight.
• Understanding of upstream and/or downstream biotechnology processes.

Responsabilidades

• Provide ongoing quality oversight to ensure CGMP/GDP compliance across manufacturing, testing, storage, and distribution.
• Drive closure of deviations, investigations, CAPAs, change controls, and validation records.
• Ensure production/testing records are complete and properly documented.
• Oversee on-the-floor analytical testing and advise on quality system improvements.
• Identify and implement continuous improvement opportunities within processes and systems.
• Support audits/inspections and interact with regulators during on-site reviews.

Conocimientos

cGMP knowledge

GDP knowledge

Biotechnology manufacturing

MS Office

Analytical testing oversight

Educación

Bachelor's degree or higher

Associate degree + 2 years

High school/GED + 4 years experience

Master’s degree

Herramientas

EBR/MES

DeltaV

Electronic Quality Systems

Descripción del empleo

Duration: 24 months contract

Description

• Shift Work Schedule (includes weekends, and possibly nights)
• Shift will be determined once identified, once shift is determined shifts will be on a stable schedule.
• Must have: Manufacturing and PQA background

Description

• The 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.
• The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements.
• 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

Responsibilities

• 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 company’s 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)s.
• 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.

Basic Qualifications

• High school/GED + 4 years’ work experience or Associate + 2 years’ work experience or Bachelor + 6 months’ work experience or Master’s Degree

Top 3 Must Have Skill Sets

• 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

Day to Day Responsibilities

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Company’s 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 Company’s 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

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

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