Quality Assurance Senior Associate

Collabera; Holly Springs (NC); On-site; USD 41,000 - 48,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Long-term disability insurance

Paid parking

Job summary

Collabera in Holly Springs, NC seeks a Quality Assurance Senior Associate to join onsite for a 12-month assignment. The role requires manufacturing and PQA background with on-the-floor quality oversight in a bulk drug substance environment.

The position involves shift-based, fully onsite work with potential nights and weekends. You will support regulatory compliance, CAPAs, deviations, and audits while collaborating with manufacturing and quality teams to ensure GMP/GDP compliance.

Qualifications

• Must have manufacturing and PQA background.
• On-the-floor QA oversight and support for bulk drug substance manufacturing.
• Ability to coach, guide and direct manufacturing events, deviations and quality systems.

Responsibilities

• Provide ongoing quality oversight to ensure products are manufactured, tested, stored and distributed per cGMP and GDP.
• Ensure facilities, equipment, materials and processes comply with GMP and related regulations.
• Drive closure and approval of cGMP documents, deviations, investigations and CAPAs.
• Ensure production and testing records are complete and compliant.
• Oversee on-the-floor analytical testing and guidance.
• Assess changes that could impact product quality per procedures.
• Investigate and document deviations per procedures.
• Alert senior management to quality, compliance, supply and safety risks.
• Provide project management support and lead system implementation efforts.
• Identify and implement continuous improvement opportunities.
• Support and represent PQA during audits and inspections.

Skills

Manufacturing experience

PQA background

Job description

Title: Quality Assurance Senior Associate

Duration: 12 Months

Location: Holly Springs NC

Description:

• Fully Onsite, 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
• Let’s do this. Let’s change the world. The North Carolina (ANC) Senior. 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 Senior 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 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.

Salary and Other Compensation:

The annual [salary/hourly rate] for this position is between $30.00 - $35.00 per hour.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

[medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance],

[paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].