Position Description Summary:
Manages and coordinates activities and operations of quality assurance department and staff. Designs, develops, implements, modifies, and evaluates SOP’s, reports and techniques to ensure a quality deliverable product according to the clients Key Element protocols.
Principal Accountabilities:
· Directs and coordinates the activities of the quality control function of the network to ensure achievement of company and client Key Element objectives.
· Responsible for creation and overall ownership of quality SOP’s. QA must approve all procedures, maintain master files and post copies to shared drive as well as send notification of targeted reviews on a timely basis.
· Responsible for finished product hold and release process and decision making.
· Responsible for overall oversight of validation program and shared responsibility of IQ/OQ/PQ processes. This role will also provide sign off for externally managed validation such as system upgrades.
· Act as site Food Safety and Defense Officer to comply with FDA Food Safety Modernization Act (FSMA) that serves as single point of contact for FSMA systems and responsible for management of the program in total.
· Ensures that quality system requirements are maintained and reported; identifies and investigates in-house quality issues.
· Oversees completion of appropriate documentation to support Key Element program.
· Evaluates current procedures and practices for accomplishing network objectives; develops and implements improvements and/or corrections as needed.
· Develops and implements primary quality control systems consistent with Key Element program and SOPs.
· Ensures that Good Manufacturing Practices (GMP’s) are always met.
· Directs and coordinates analysis of products in and out of compliance with GMP regulations and Key Elements. Provides management with timely reviews of the networks status and progress.
· Reviews all data generated in support of the Quality Assurance program; oversees preparation of reports and summaries based on data.
· Directs, facilitates, coordinates and participates in Key Element audits and assumes ownership / leadership of process.
· Coordinates with client, and senior staff to identify and implement opportunities for continuous improvement processes to reduce costs and increase and/or improve quality for all network activities and client service.
· Ensures that network operations comply with federal, state, local, and/or company policies and regulations.
· Interacts and collaborates effectively with internal and external team members to assure needs of the company are met.
The individual in this position must be capable of performing all of the essential functions with or without a reasonable accommodation.
Benefity:
Medical
We offer a number of plans for a variety of health care services and supplies, including preventative care, inpatient and outpatient services and prescription drugs.
Vision
The option for separate vision coverage for eye exams, frames, and contact lenses.
Dental
The option for separate dental coverage to cover preventative major and basic dental services.
401(k)
The company offers a pre-tax 401(k) contribution plan with a company match.
Direct Deposit
We offer direct deposit to all employees.
Holidays
On a calendar year basis, the Company pays all employees 6 major holidays, including New Year's Days, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Christmas Day.