cGMP Quality Support SpecialistAkkodis • Atlanta, GA, US

cGMP Quality Support Specialist

Akkodis • Atlanta, GA, US

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cGMP Quality Support Specialist job in the Atlanta Metro area

Long term contract

28.00 / hr-30.00 / hr The rate may be negotiable based on experience, education, geographic location, and other factors.

Akkodis is seeking to fill a cGMP Quality Support Specialist job in the Atlanta, GA metro area. The successful candidate will Maintain a comprehensive quality control program to ensure that cGMP standards and other regulatory guidelines are adhered to by SNS staff, during the receipt, storage, handling, transport, and distribution of pharmaceutical products.

cGMP Quality Support Specialist job responsibilities include :

1.Maintain a comprehensive quality control program to ensure that cGMP standards and other

regulatory guidelines are adhered to by SNS staff, during the receipt, storage, handling, transport,

and distribution of pharmaceutical products.

Monitor all quality assurance aspects of the program and recommends program modifications or

revisions when necessary.

Conduct audits of facilities, on a regular basis, to document cGMP compliance and identify

deficiencies.

Review facility data and documentation to ensure all quality assurance requirements are in place,

controlled, and meet cGMP and other regulatory requirements.

Investigate deviations which pose a significant risk of adversely impacting products, determine the

cause of the problem and develops corrective and preventive actions.

Maintain an interpersonal relationship with program officials, key staff within ASPR, HHS, other

Federal agencies, key contract partner representatives, members of the science-based academic

community, to resolve any issues with the quality control programs.

Serve as a member of the Quality Control Unit (QCU) jointly responsible for ensuring compliance

with applicable current go cGMPs for the storage and transportation of finished pharmaceuticals.

Develop audit plans and establish cGMP audit criteria; assess deficiencies and / or discrepancies and

suggest / implement corrective action as needed to maintain cGMP / FDA compliance. Report

compliance deficiencies to management as required.

Analyze and evaluate internal cGMP controls, policies and procedures. Propose recommendations

and provide support for cases of non-compliance, missing policies, lack of controls, and other

operational improvements. Assist in writing SOPs and protocols where applicable and provides

quality control and regulatory expertise.

Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.

Ensure compliance with established internal cGMP control procedures by examining records, reports,

operating practices, and documentation. Coordinate and conduct periodic internal audits as well as

audits of contract partners.

Assist and assure cGMP compliance with applicable regulatory requirements, industry standards, and

program Quality System policies. Make continuous improvements to the Quality Systems to execute

and implement current Good Manufacturing Practices and to increase system efficiency.

Minimum Requirements : Bachelor's Degree or equivalent plus the following :

A minimum five (5) years of quality control / quality assurance experience in the pharmaceutical

industry providing oversight to QC / QA tasks / projects and other cGMP oversite responsibilities.

Expertise in maintaining regulatory compliance—including during PHE responses—with cGMP,

inventory systems validation, FDA regulatory guidance, and 21 CFR (Parts 11, 210, 211, 600 and

800)

Knowledge of FDA and industry standard cGMP related guidance and quality management

principles.

Strong knowledge of relevant FDA regulatory guidance.

Physical Demands / Surroundings - The duties of this position may require the individual to exert

some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight

is typically no more than 25 pounds.

f you are interested in the CGMP Quality Support Specialist job in the Atlanta GA, metro area then please click APPY NOW. For other job opportunities available at Akkodis go to www.akkodis.com If you have questions about the position, pleases contact Marie Badger at marie.badger@akkodisgroup.com today. Referrals are greatly appreciated.

Equal Opportunity Employer / Veterans / Disabled

Benefit offerings could include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, 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. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https : / / www.modis.com / en-us / candidate-privacy /

The Company will consider qualified applicants with arrest and conviction records.

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Quality Specialist • Atlanta, GA, US