What are the responsibilities and job description for the Quality Assurance Manager position at Hanford Pharmaceuticals?
Scope of Position
Manage assigned staff to monitor the operations and performance of the Quality Assurance team. Ensure departmental operations and documentation comply with standard operating procedures, government regulations, and customer requirements. Ensure company programs comply with regulations, guidelines, and industry standards. Assist in maintaining budget and acting as liaison with both internal and external entities. Assist with recruiting and selection process for department.
Key Position Responsibilities
- Manage Quality Assurance Department – Provide guidance and support to supervisor in management of Quality Assurance team including overseeing team performance. Manage department to ensure team members are working toward company and departmental goals. Participate in performance management and other Human Resources related items. Manage operations of department among all company facilities and production shifts. Participate in recruitment and selection process.
- Documentation Review and Approval – Review and approve Production and Quality documentation including but not limited to Batch Records, Deviation Reports, SOP’s, Investigative reports, etc., to ensure completeness, accuracy and compliance with procedures, regulatory guidelines, and industry/customer expectations.
- Document Preparation/Revision - Prepare/revise SOPs, sample plans, and other production documents as required. Investigate and write reports, provide status reports and updates per procedure for deviation and investigation reports CAPA.
- Department Representative – Attend internal and external meetings as directed by Department Head to include management meetings, FDA and customer audits and inspections. Provide CAPA updates and input on departmental metrics.
- Acts as Departmental Liaison - Contact customer(s) on quality issues as applicable. May assist with customer and/or supplier audits. Act as liaison internally and cross departments.
Education and Experience
Bachelor’s Degree in science or equivalent. Previous supervisory experience preferred. 3 to 7 years in quality assurance field preferably in a regulated environment.
Certificates, Licenses, Qualifications
ASQ (CQA, CQI, CQE) beneficial but not required.
Why work at this Company?
If you want to be part of an employee-centered, dynamic organization, we are adding staff in many departments. Come grow with us!
Company Description:
Privately owned and operated since 1846, Hanford Pharmaceuticals is a highly respected contract manufacturer specializing in manufacturing and filling sterile, injectable antibiotics, non-sterile intra-mammary infusions and other pharmaceutical products for veterinary and human use. We offer a competitive salary and benefits package including Roth accounts and 401(k) with an employer match, 12 paid holidays, employee appreciation programs, excellent medical and dental insurance plans, generous vacation benefits, and more! EOE
Job Type: Full-time
Pay: From $85,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
Salary : $85,000