Role Description Summary
Have 3-5 years of relevant experience in a pharmaceutical solid oral dosage manufacturing quality department. Have an excellent working knowledge of regulatory requirements, have a strong attention to details, be an effective communicator across all levels of the organization, and possess a strong desire to continuously help us get better. Under limited supervision, ensures compliance with current Good Manufacturing Practices and Company policies, procedures and specifications.Description of KEY responsibilities (describe the main results of the job to be achieved):
·Carries out leadership and training responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Takes custody retains and stores retention samples of filled-labelled bottles and inserts for each production lot; maintains accountability for the status designation labelling.
Product Retention (i.e. Finished Good, Raw Materials, and Components) Inventory Control.
Inventory of controlled substances and non-controlled substances
Complete DEA paperwork for transfer of DEA materials/products across Actavis sites.
Data entry of samples received into QAD and WDMS.
Pull samples as needed.
Performs monthly visual inspections.
Performs complaint inspections of retains.
Perform destruction of expired retains.
Generation of product annual retention report data (as requested).
Generation of DEA retain data as requested.
Conduct annual inventory of DEA retain samples per Corporate guidelines.
Inventory reporting to department management, Supply Chain, and DEA Compliance as required.
Training of retention personnel.
Subject matter expert for retention samples in QAD and WDMS.
Perform testing for customer complaint and deviation investigations, as needed.
Notifies supervisor of any deviation, incident and/or non-conforming situations, and assists in the investigation of situations and the internal audit program.
Leads and completes special projects as assigned.
Performs duties in a timely manner, adhering to all cGMP regulations, Corporate, Company and site good housekeeping, safety and operating policies and procedures
Experience and education required
High School Diploma or GED required
3-5 years experience in a relevant Quality Assurance environment.Skills and specific knowledge required
Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory compliance regulations and standards.
Quality control practices in the pharmaceutical industry.
Leadership, project management and training methods and techniques.
Principles of mathematical and statistical computations.
Must be well organized, detail-oriented, and experienced in working with minimal supervision.
Must possess excellent verbal and written communication skills.
Must be able to work flexible schedule to include holidays, weekends and off-shift.
Must be willing to work in either Elizabeth or Edison, NJ.
Experience using Microsoft Office applications, including Word and Excel, and data entry experience is a plus.
Must have the ability and willingness to interact and work with various individuals at all levels in the organization.
Thorough knowledge of cGMPs.
Must work safely at all times and comply with all safety policies and procedures.
Must demonstrate proficient PC skills.
Core competencies identified
Equipment and Applications
Weight Variation Machine
Work Environment and Physical Demands
Incumbents in this class are subject to extended periods of sitting, standing, walking, bending, stooping, crouching, climbing, vision to monitor, moderate noise levels, and lifting, pushing, pulling parts and equipment up to 20 pounds.
Visual acuity with ability to accurately decipher colors required.
Please refer to "Qualifications"