Quality Control Coordinator (Bilingual) - 2nd shift

The Bilingual (Spanish) QC Coordinator is tasked with developing, training and growing Quality Control Inspectors. The Leader’s responsibility include conducting inspections, identifying production, process or product issues and presenting solutions. 

Responsibilities:

• Ability to perform all job duties of the Quality Control Inspector.
• Act as a liaison between Quality Control Inspectors and QC Management.
• Assist all manufacturing managers in various quality related matters.
• Ensure the Quality Control Inspectors understand line/ and or room clearance
• Train new Quality Inspectors to understand the batch record and the batch record reconciliation in all phases of the manufacturing process.
• Ensure that the line clearances are performed per product in all manufacturing areas.
• Ensure that packers and operators in all areas understand all quality aspects of their position.
• Coordinate with Quality to ensure that all documents are properly reviewed and approved.
• Ensure the inspection and sample retention of all processes are being taken, at the actual manufacturing process, and documented on the correct forms and retained correctly.
• Assist fellow employees with their tasks per manager’s instruction
• Adhere to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices.
• Conduct thorough inspections of staged raw materials in pharmacy, in-process components in manufacturing and packaging, and finished products to ensure they meet quality standards.
• Perform routine in-process checks using established methods in manufacturing and packaging to verify product quality, integrity, and safety.
• Inspects the lines and/or room clearance for pharmacy, blending, manufacturing, and packaging.
• Inspects all processes of the departments as assigned.
• Inspects the information white board at each phase of the process to confirm the work-in-process products match records on hand.
• Review the batch record and the batch record reconciliation in all phases of the manufacturing process.
• Accurately document in-process checks, inspection results, and deviations from approved standards like batch records.
• Maintain comprehensive and up-to-date records of quality control activities like sample logs, retains, temperature logs, cleaning logs for rooms/lines etc.
• Ensure the inspection and sample retention of all processes are being taken, at the actual manufacturing process, and documented on the correct forms and retained correctly.
• Collaborate with cross-functional teams as needed.
• Responsible for communicating quality defects with supervisors.
• Assist as needed in providing information or retain samples required to complete investigations for customer complaints, deviations and/or CAPA.
• Work at different stations as production requires.
• Maintain a clean and safe work environment.
• Show a desire and willingness to learn and succeed.
• Complete all required training activities.
• Demonstrate a commitment to the organization by maintaining regular, on-site attendance, act in a reliable manner and follow through on responsibilities.
• Other duties as assigned.

Qualifications:

• Experience in Quality and/or Manufacturing in a cGMP environment.
• Knowledge of quality systems, cGMP, and Good Documentation Practice (GDP).
• Proficient computer skills including Microsoft Office applications.
• Able to work in a timely manner in a fast-paced environment.
• Strong organizational skills, multitasking, and attention to detail.
• Strong experience of Microsoft Excel.
• Excellent communication skills and ability to work in a team.
• Strong willingness to learn and grow.
• Basic math skills, keen observation ability.
• Bilingual, must be able to read and write English.

Schedule:

40 hour week

Mon-Thurs, 2nd shift, 3:30 p.m. - 2:00 a.m.

Benefits

• Health insurance
• Dental insurance
• Sick days
• Paid holidays
• Vision insurance
• Life insurance
• 401(k) matching