What are the responsibilities and job description for the Senior Quality Assurance Inspector position at Medvacon Life Sciences?
This is a temporary contracted position Important Notice : Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com . If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com . DURATION - 6 MONTHS - ONSITE POSITION - SHIFT - MON-FRI 8 : 30AM - 5PM. Quality Operational Specialist supporting manufacturing department quality-related activities. Candidate should have prior GMP inspection and documentation quality review experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail-oriented in a fast-paced multi-task environment with good oral and written communication skills and can interact with all levels of management and other supporting departments.
- Conduct audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate and pharmaceutical development SOPs
- Perform QA Room Releases, line clearances, equipment releases and AQL inspections as required.
- Provide Quality Floor supports during batch manufacturing by performing routine Quality auditing.
- Provide QA support to Manufacturing for clinical and commercial batches
- Audit of executed Batch Records for compliance with CGMP and provide customer audit responses as required
- Audit of raw materials, facility logs, release data.
- Interdepartmental communication for obtaining information and audit corrections
- Comply with and ensure compliance of the department with Health, Safety and Environmental responsibilities
- Assist with batch investigations as required
- Able to work over the weekend and stay outside business hours if required as direct by the department manager.
- Assist other duties assigned by manager to support the department and business. Education or Equivalent Requirements :
- High school diploma or equivalent (GED) with 8 years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing. Knowledge / Skills Requirements :
- Good understanding of compliance regulations and audit techniques.
- Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
- Full understanding of FDA, CGMP, and DEA regulations pertaining to Pharmaceutical manufacturing
- Good mathematical skills
- Safety procedures associated with department.
- Read and understand MSDS requirements and restrictions.
- Understand procedures related to document control, Quality Assurance and this job function.
- Candidate must have ability to work effectively under high pressure on multiple projects.
- Candidate must have detail oriented with effective oral and written communication skills. Physical Requirements :
- On average 8 hours day this position requires the ability to work, sit and stand.
- Ability lift up to 15-30 pounds when required to perform the routine assigned duty task.
- Ability to perform the task wearing Personal Protection Equipment (PPE), such as eyeglasses, respirator, etc. WORK ENVIRONMENT / SAFETY CONSIDERATIONS This position works in a high-pressure, fast-paced manufacturing facility with the QA support requirement to meet multiple deadlines while paying strict attention to details. The position demands responsive and clear oral and written communication and good interpersonal skills. This function will demand a high volume of QA operational support to meet manufacturing schedules during assignments working shifts with occasional weekends and extended hours as required by department and business needs. This position will involve interacting daily with manufacturing, facility, Quality Assurance, and other supporting department groups. Important Notice : Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com . If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com . Powered by JazzHR
