QA RA Compliance Specialist

Adecco is currently assisting a local client in their search to fill a QA RA Compliance Specialist position in St. Petersburg, FL . Apply now!

The anticipated wage for this position is between $29 and $30. Hourly wage may depend upon experience, education, geographic location and other factors.

Job Duties :

Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.

Provide initial regulatory impact assessment on all change controls as required.

Liaise with customers to ensure customer requirements are satisfied.

Preparation and submission of A / NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant / site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required

Prepare and submit all federal, state and local permits in timely manner

Interact with Customers and gather information as needed to support registration activities

Assist in the preparation of standard operating procedures (SOPs) associated with job function; review and approve SOPs requiring the regulatory function participation under direction of the Group Leader

Assist in regulatory / health authority audits collecting information as requested

Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution

Education / Requirements :

Bachelors Degree in Science or related field required (Chemistry, Microbiology or Biology);

A minimum of 3 years related experience in the pharmaceutical manufacturing industry.

Strong background working with Change Controls and management of change control processes.

Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

If you would like to be considered for this position, Please Apply Now!

Pay Details : $29.00 to $30.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer / Veterans / Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers

San Francisco Fair Chance Ordinance

Salary : $29 - $30