QA/QC Specialist

QA/QC Specialist Position

We are looking for a Full-time qualified QA/QC Lab Technician to undertake a variety of laboratory procedures within the consumer goods industry. Candidates must be able to prioritize work and multitask with a very high attention to detail and accuracy in a fast-paced work environment. Provide Quality Assurance support for the manufacturing, packaging and warehouse by performing testing, visual inspections, audits and reviewing documentation for accuracy. Follows all pertinent guidelines and SOPs to ensure cGMP compliance.

Responsibilities:

• Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
• Provide Quality Assurance support involving manufacturing production issues
• Ensure that products are manufactured in compliance with site, regulatory and cGMP guidelines
• Perform QA reviews, product shipment releases, training records, deviations, and Quality System issues
• Maintain compliance with SOP, cGMP, and regulatory guidelines
• Ensure timely issuance of production records and labels
• Elevate issues affecting lot production or release to Management in a timely manner
• Ensure approval and timely delivery of Final Product
• Review and approve executed Manufacturing Production Records as per compliance
• Compile and verify all batch-related documents into a Final Product lot disposition package
• Performs audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems
• Attends and assist in all audits and ensures that all audits (internal and external) are performed, documented, reviewed, and closed.
• Assists in, conducts, and evaluates center training and orientation programs
• Perform quality inspections prior to the processing of all incoming materials, as per specifications.
• Ensure that all safety guidelines are followed.
• Gather information for use in continuous improvement of areas of responsibility, as needed

Skills:

• Bachelor’s degree in technical discipline (Microbiology/Chemistry/Engineering or related field)
• Quality certifications preferred (i.e. ISO, Six Sigma, Lean, auditor)
• Working knowledge of cGMP, quality inspection and FDA requirements
• Minimum of 3 years of experience in QA/QC with strong follow-up skills
• Experience with Health Authority Regulations and Validation practices/principles
• Experience with identifying deviations and implementation of corrective action programs (CAPA)
• Experience with internal and external audit
• Experience with refining processes and creating documentation (preferred)
• Strong computer skills including Microsoft Office, Advanced Excel skills, pivot table, and databases
• Ability to communicate and work independently with scientific/technical personnel and attention to details
• Proactive and able to anticipate business needs, provide solutions and embrace challenges
• People skills and cross functional collaborative skills required.
• Ability to work autonomously and under pressure.

Job Type: Full-time

Pay: $39,000.00 - $44,000.00 per year

Schedule:

• 8 hour shift

COVID-19 considerations:
All Candidates required to wear masks for interview.

Education:

• Bachelor's (Preferred)

Experience:

• Quality Control: 3 years (Preferred)
• Microsoft Office: 3 years (Preferred)
• QA/QC: 3 years (Preferred)

Language:

• English (Preferred)

Visa Sponsorship Potentially Available:

• No: Not providing sponsorship for this job

Work Remotely:

• No

COVID-19 Precaution(s):

• Personal protective equipment provided or required
• Temperature screenings
• Social distancing guidelines in place
• Sanitizing, disinfecting, or cleaning procedures in place