Quality Assurance Senior Quality Control Specialist
3 weeks ago
Job Title: Quality Assurance Senior Quality Control Specialist
Location: New Jersey, USA (Open to U.S. Citizens; locals preferred)
Position Type: Contract
Estimated Salary: $38 per hour based on national averages for a quality assurance senior inspector in the pharmaceutical industry.
About ProQuality Network:
ProQuality Network is a trusted recruiting partner for the pharmaceutical, biotech, and medical device industries. We connect top-tier professionals with rewarding contract opportunities that allow them to make a meaningful impact in their field.
Job Overview:
The Quality Assurance Senior Quality Control Specialist will provide critical quality support to the manufacturing department, ensuring compliance with cGMP, DEA regulations, and internal SOPs. This role demands precision, attention to detail, and the ability to operate in a dynamic, fast-paced environment.
Key Responsibilities:
- Conduct facility audits to ensure compliance with cGMP, DEA, and internal SOPs, ensuring that all aspects of the facility meet regulatory requirements.
- Perform QA room releases, line clearances, equipment releases, and AQL inspections as required, guaranteeing the highest level of quality control throughout the manufacturing process.
- Provide Quality Floor support during batch manufacturing through routine auditing, ensuring that all batches meet quality standards.
- Support manufacturing activities for clinical and commercial batches, working closely with cross-functional teams to ensure seamless production.
- Audit executed batch records and raw material documentation for cGMP compliance, identifying areas for improvement and implementing corrective actions as needed.
- Prepare customer audit responses and facilitate interdepartmental communication for obtaining and correcting audit-related information, maintaining open lines of communication with stakeholders.
- Participate in investigations and provide detailed documentation for batch discrepancies as required, taking a proactive approach to resolving issues.
- Comply with Health, Safety, and Environmental responsibilities, upholding the company's commitment to sustainability and environmental stewardship.
- Assist in other duties assigned by the department manager to support departmental and business needs, demonstrating flexibility and adaptability in a fast-paced environment.
Qualifications:
To succeed in this role, you will need:
- A high school diploma or equivalent (GED) with 8+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing within the pharmaceutical industry.
Requirements:
We are looking for a skilled professional who possesses:
- A strong understanding of compliance regulations, including FDA, cGMP, and DEA requirements for pharmaceutical manufacturing.
- Knowledge of quality auditing and evaluation techniques, with the ability to apply these skills in a fast-paced environment.
- Excellent mathematical, oral, and written communication skills, with the ability to effectively communicate complex information to stakeholders.
- Ability to multitask effectively under pressure, prioritizing tasks and managing multiple projects simultaneously.
- Proficiency with documentation control and quality assurance procedures, with a focus on accuracy and attention to detail.
Physical Requirements:
This role requires:
- Ability to sit, stand, and work for extended periods, with occasional lifting of 15-30 pounds as needed.
- Comfortable wearing Personal Protection Equipment (PPE), such as safety glasses and respirators, when required.
Work Environment:
This position operates in a high-pressure, fast-paced manufacturing facility requiring exceptional attention to detail, communication, and interpersonal skills. Interaction with cross-functional teamsincluding manufacturing, facilities, and QAis essential to meeting production schedules and quality standards. Flexibility for weekend work and extended hours may be required to support business needs.
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