Sr. Specialist, R&D QA

Actavis, Inc.
Job Location
Elizabeth, NJ
Job Description

Under general supervision, responsible for ensuring that R&D activities are in compliance with cGMPs and Company Standards. Reviews both R&D operations and analytical processes, protocols, reports and testing results and provides unbiased recommendation either to approve or reject incoming raw materials and finished products. Ensures that clinical batch (i.e. Pilot bio batch, E-batch) manufacturing activities are compliant with cGMPs. Ensures that R&D facilities and equipment are cGMP compliantDescription of KEY responsibilities:
Reviews and approves both Processes (Mtg) and Analytical documents such as process batch records, method validation protocols and reports and process development reports, to ensure compliance with internal procedures and regulations
Attends project meetings to provide cGMP and FDA guidance and problem analysis to ensure timely release of batches for bio-studies and/or submission requirements to avoid delays for the new product
Reviews and approves laboratory investigations and deviations to evaluate quality impact, as well as change controls related to methods and lab equipment
Reviews and approved Lab Equipment Qualification protocols and reports, and participated in review and approval of lab equipment related SOPs
Assists with PAI inspections/audits documents for PAI readiness
Reviews and approves CoAs for bio-studies release and regulatory submission. Helps performing in process testing during the manufacturing process, as well as, pilot plant equipment clearances (CV releases


Experience and education requiredEssential:
BS/BA Bachelor's Degree in Chemistry or related field from an accredited college or university
5 to 10 years in pharmaceutical industry environment, or an equivalent combination of education and experience

Quality assurance experience in an R&D pharmaceutical environment.

Skills and specific knowledge required

Knowledge in GxP and FDA regulations as applicable to R&D
Thorough understanding of different manufacturing technologies (Solid-dose, Liquids and Creams etc.); and analytical laboratory operations
Highly motivated self-starter
Outstanding analytical, creative thinking and problem solving skills
Detail oriented, well organized and the ability to multitask
Excellent communication skills, both oral and written
Ability to work both independently and as a member of a team
Managing multiple projects, duties and assignments
Experience with facilitating in a team environment
Excellent interpersonal skills, including a strong ability to work in a consultative manner with every level of internal and external customer, including senior management
Willingness and ability to work flexible schedule as needed
Proficient in computer hardware and software application usage.

Ability to effectively present information to employees, colleagues, third party vendors and other external contacts
Knowledge of TrackWise, QUMAS, Livelink (Hotdox)

Core competencies identified

Managing change
Attention to oral and written communication
Influencing others
Analytical and Strategic thinking
Stress management

Please refer to "Qualifications"

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