Junior Manufacturing Qa Specialist

Position Overview: The Junior Manufacturing QA Specialist will support the quality assurance activities within our manufacturing facilities, ensuring compliance with regulatory requirements and adherence to GMP standards. This entry-level position offers hands-on experience in pharmaceutical manufacturing and quality control processes, with opportunities for growth and development in the field of QA. The ideal candidate will have a strong attention to detail, excellent communication skills, and a commitment to upholding quality standards.

Key Responsibilities:

1. Quality Assurance Support:

   • Assist in the implementation and maintenance of quality assurance programs and systems to ensure compliance with GMP regulations and company policies.
   • Perform routine inspections and audits of manufacturing processes, equipment, and facilities to verify compliance with established quality standards.
   • Support the review and approval of manufacturing batch records, standard operating procedures (SOPs), and other documentation to ensure accuracy and completeness.

2. Documentation and Record Keeping:

   • Maintain accurate and up-to-date records of quality assurance activities, including inspection reports, non-conformance records, and corrective action plans.
   • Assist in the preparation and submission of regulatory documentation and reports, such as batch release documentation and product quality reviews.

3. Quality Control Testing:

   • Assist in the collection and testing of in-process and finished product samples, performing visual inspections, physical measurements, and analytical tests as required.
   • Document test results accurately and communicate deviations or out-of-specification findings to senior QA staff for further investigation and resolution.

4. Training and Compliance:

   • Participate in training programs and workshops to develop knowledge and skills in pharmaceutical manufacturing processes, quality assurance principles, and regulatory requirements.
   • Ensure personal compliance with company policies, procedures, and safety guidelines, and promote a culture of quality and compliance among colleagues.

Qualifications:

• Bachelor's degree in Chemistry, Biology, Pharmacy, or related field.
• 1+ years of experience in a pharmaceutical manufacturing environment, with exposure to GMP principles and practices preferred.
• Familiarity with quality assurance concepts, including batch record review, documentation control, and deviation management.
• Strong attention to detail and the ability to perform accurate and precise measurements and calculations.
• Excellent communication skills, both verbal and written, with the ability to collaborate effectively with cross-functional teams.
• Proficiency in Microsoft Office Suite and experience with electronic document management systems (e.g., Documentum, TrackWise).

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