Hybrid Pharmaceutical Compliance Specialist III

Employer
Akkodis
Location
Framingham, Massachusetts
Salary
Negotiable
Posted
Apr 01, 2024
Closes
Apr 04, 2024
Ref
2741909216
Position Type
Specialist
Hours
Full Time
Practice Setting
Supplier / Manufacturer
Work Mode
Hybrid
Employment Type
Contract
Organization Type
Corporation / LLC
Akkodis is seeking a Hybrid Pharmaceutical Compliance Specialist III for a 12-month contract position with a client located in Framingham, MA. You will ensure the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of the Company in accordance with cGMP's and Company Quality directives. This role requires being onsite one to three days a week.

Pay/Salary Range: $50.00 to $55.00 per hour

Hybrid Pharmaceutical Compliance Specialist III job responsibilities include:

• Ensures the efficiency of Quality System implemented between the Company and the sub- contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements.

• Leads projects as assigned such as new product launch teams.

• Identify and leads the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to Company products.

• Collaborates with subcontractors to find and implement solutions concerning quality issues.

• Respond to customer complaints, including close out and determination of corrective actions by collaborating with CMOs and identifying trends.

• Identify and prevent or resolve issues that could impact the continuity of supply of existing products.

• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations. Identify trends to reduce Quality anomalies.

• Stay in constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality.

QUALIFICATIONS:

• Bachelors Degree

• Five to seven years of experience specific to Pharmaceutical Operations or Quality Operations with the application of cGMP's in the Pharmaceutical or related regulated industry

• Must have experience with deviations, change controls, compliance management, pharmaceutical product release experience, CAPA's, etc.

• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience

• Possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations

• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations

• Project management skills

• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship

• Excellent oral and written communication skills in cGMP documentation.

If you are interested in this Hybrid Pharmaceutical Compliance Specialist III job in Framingham, MA then please click APPLY NOW. For other opportunities available at Akkodis go to .

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

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

Pay Details: $50.00 to $55.00 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

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.