Assistant Manager - Quality Assurance Manufacturing

Job Description

Job Description

PREFERENCE WILL BE GIVEN TO LNK EMPLOYEES. THIS JOB POSTING IS FOR 5 DAYS ONLY.

Title: Quality Assurance Manufacturing Assistant Manager

Reports To: QA Manager

Personnel Reporting to Position:

QA supervisors, QA inspectors, Warehouse QA, Operations QA.

Minimum Education or Experience Required:

Associates degree or higher. Must be proficient in GMP's and have previous experience with SOP's, validation protocols, and implementing procedures in a pharmaceutical environment. Experience supervising and training people, and computer expertise is a must.

Areas of Responsibility: All Quality Assurance activities related to the manufacturing and releasing of drug products to insure complete and timely availability of product within FDA GMP regulations. This includes but is not limited to: staffing of QA personnel, developing and maintaining QA personnel, training and safety programs, regulatory compliance, and insuring all Human Resources policies are followed. The QA Assistant Manufacturing Manager will work closely with other department heads to insure the smooth flow of materials, paperwork and information to ensure that manufacturing complies with GMP guidelines.

Drug Product Manufacturing:

1. Ensure cGMP compliance in all Manufacturing areas. Establish and execute polices, procedures and practices for regulatory compliance in the product release area.
2. Review of pertinent Deviations/investigations when necessary. Tracking of deviations and investigations to determine trends.
3. Oversee the approval and execution of Master Formulas. Review and approval of validation protocols, cleaning validations, and qualification protocols and summary reports for manufacturing. Review and approval of all in-process forms related to the manufacturing of products.
4. Monitoring of change control system; temperature monitoring program in all areas of responsibility, including recordkeeping of temperature logs/charts.
5. Ensure company SOPs are adequate and meeting GMP standards. This may include Approval/Creation of SOP's.
6. Responsible for the execution and reporting to management of internal audit findings and follow up corrective action summary reports. Ensure the documentation and execution of CAPAs and Quality monitoring Plans. Implement and assist in CAPA plan
7. Responsible to review APR report. Also responsible for noting trends and informing appropriate personnel for corrective action.

This position requires the ability to stand for long periods of time, and travel between buildings. Hours may vary to ensure both day and night shift are monitored.

This posting is for internal candidates only.

Job Posted by ApplicantPro