Sr. QA Supervisor

Purpose: A Huntsville area Pharmaceutical Company is seeking a QA Specialist to assure all operations are performed in compliance with company procedures and Quality Standards.

Description:
Monitors designated phases of the manufacturing operations.
Writes, revises, reviews, and approves standard operation procedures and related manufacturing documents.
Conducts investigations related to manufactured products.
Generates reports.
Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
May also support various project development teams by providing quality over sight of development activities.
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Acts independently to determine methods and procedures on new assignments.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Uses professional concepts to achieve objectives in creative and effective ways.
Performs batch record review, including resolution of investigations and deviations to meet time lines.
Performs lot disposition.
Interfaces with pharmaceutical partners on quality and product issues, and FDA during cGMP audits.
Participates in the performance internal and external audits in accordance with current regulatory compliance.
Participate in Quality investigations utilizing QA tools and follows up on corrective actions to closeout.
Participates in Quality Oversight of Contract manufacturing, acting as person-in-the-plant.
Performs data audits and report reviews as required.
Identifies procedural and systematic compliance risk and recommends practical corrective actions that complement functional area business processes.
Reviews regulatory filings.
Develops and delivers training courses.
Approves specific procedures, master batch records, specifications and critical process parameters, discrepancy investigations and batch release as designated by higher level.
May provide supervision to junior staff.

Requirements:
8 years of Pharmaceutical experience.
Strong written and oral communication skills.
In-depth knowledge of FDA regulations and cGMP.
Supervisory experience is a must.

Classification:
Direct Placement

Compensation:
N/A Year

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
FDA, CGMP, regulatory filings, BS degree, 8 yrs pharma experience, Batch Record ReviewContact Information
Contact:Bebee,Haley C