Ardena Careers · 13 hours ago
Quality Assurance Operations Auditor
Somerset, NJ
Contract
Onsite
Mid Level
$80K/yr - $90K/yr
3+ years expArdena is a leading Contract Development and Manufacturing Organization (CDMO) that partners with pharmaceutical companies to facilitate drug development. The Quality Assurance Operations Auditor role involves ensuring compliance with regulations through routine auditing, providing QA support, and participating in quality systems management.
Pharmaceuticals
Responsibilities
Routine auditing of the Manufacturing Facility area to ensure compliance with cGMPS, DEA, FDA, and local site procedures
Provide QA support to manufacturing for clinical and commercial batches and other GMP activities
Performs Line Clearances, equipment releases and, AQL inspections, and in process checks of manufacturing processes and other quality check define by the procedures
Execution, review, approval and maintaining QA department logbooks as per SOP example but not limited to QA HOLD, Rejection, PBR tracker etc
Audit of raw materials, warehouse, and facility logs
Review and approval of Cleaning Batch Records (CBR) and Production Batch Records (PBR)
Review and approval of Master Batch Record (MBR)
Provide coaching, guidance, and training for employees
Assists with various quality systems record quality review and closure, like deviation, complaint, change control, OOS/OOT etc
Hosting routine Change Control committee, Deviation Review Committee (DRC) and Root cause/CAPA meetings
Review of equipment repaired workorder for quality/compliance impact assessment
Create, revision and approval of the site SOP
Participate in site non-conformance investigation as QA representative
Support site on quality review and approval of quality systems record closures an example deviation, change control, complaint etc
Actively participate in any process associated with continuing improvement program implementation at Somerset site level
Review and approval of analytical department document an example, CoA, Stability report, Method validation, protocol, Micro report etc
Performing annual Retain sample inspection
Issuance and reconciliation of CBRs and PBRs
Performing approval/rejection of final batch disposition release decision
Review, Approval, and Release of Raw Materials
Interdepartmental communication for obtaining information
Supporting the various audit activities like regulatory, customer, internal etc., as necessary
Addressing the customer Quality observation
Comply with and ensure compliance of the department with Health, Safety, and Environmental responsibilities
Assist with quality event processes and batch investigations as required
Flexible working on different shifts as required
Weekend work to support manufacturing as required and working extra hours during weekdays as required
All other duties as assigned by a manager to support the department and business
Qualification
Required
Minimum bachelor's degree or higher equivalent with 3+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing or engineering
Good understanding of compliance, regulations and inspection techniques
Thorough knowledge of cGMP, ability to evaluate facilities records, processes, procedures, and practices for conformance to these requirements
Understanding of FDA, cGMP and DEA regulations pertaining to Pharmaceutical Development
Good mathematical skills
Good computer skills, including in depth knowledge of Word and Excel
Safety procedures associated with the department
Read and understand SDS requirements and restrictions
Understand procedures related to document control, Quality Assurance and its job function
Candidate must have the ability to work effectively under high pressure with multiple project deadlines
Candidate must be detail oriented with effective oral and written communication skills, team oriented with effective interpersonal skills
Candidate must be responsive to timelines and adjust priorities as required
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
Ability to work wearing Personal Protective Equipment (PPE), such as, eye glasses, respirator, etc
Mathematical and reasoning ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to work effectively under pressure to meet deadlines
Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment
Specific vision requirements include reading of written documents and use of computer monitor screen frequently
Individuals may be required to lift 10-15 pounds
Excellent computer skills and diversity of software experience
Communicates effectively with other departments and vendors
It should be recognized as a technical resource of defined scope for routine issues
Keeps management apprised of the status of work
Must be able to work effectively with operations personnel
Benefits
Medical, dental and vision benefits effective day one of employment
Paid Time Off
A dynamic, global work environment with career growth opportunities
Access to Ardena Academy, our internal learning platform for professional development
A chance to contribute to groundbreaking drug development projects that make a real impact
Company
Ardena Careers
Find your career path with Ardena At Ardena, we’re more than a global Contract Development and Manufacturing Organization (CDMO) - we’re a team of innovators, problem-solvers, and experts dedicated to advancing drug development.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase