Senior QA Associate - Manufacturing And PQA
Overview
Job Description
Sr. QA Associate - Manufacturing and PQA
Location: Holly Springs, NC
Onsite Flexibility: Onsite
Contract Details
- Position Type: Contract
- Contract Duration: 24 months
- Pay Rate: $30.00 $35.00 / Hour (USD)
- Shift / Schedule: Shift work schedule (includes weekends and possibly nights); shift will be determined once identified once confirmed, shifts will be on a stable schedule
- Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Job Summary
The Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for ongoing 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.
Key Responsibilities
- Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems, and process with alignment into the Amgen Quality Systems; may include support on commissioning and qualification and validation activities in addition to new document support
- Provide ongoing 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 requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
- Drive closure/completion (including review and approval) of cGMP processes, procedures, documents, and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPAs), 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
Required Skills
- 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
- Manufacturing and PQA background
Education Requirements
- High school diploma/GED 4 years of work experience, OR Associate's degree 2 years of work experience, OR Bachelor's degree 6 months of work experience, OR Master's degree
Required Experience
- Minimum experience as specified per education tier: 4 years (High school/GED), 2 years (Associate's), 6 months (Bachelor's), or 0 additional years (Master's) in a relevant field
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
Important Notes
- The role will be sourced at open market rate
- Must have Manufacturing and PQA background
- Interview process: 2 panel interviews
About GTT
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number: 26-17751 Industry: Manufacturing & Operations
#LI-Onsite #gttic #gttmf
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