CTG Pharmaceutical Product Quality Assurance in Myerstown, Pennsylvania
Title: Pharmaceutical Product Quality Assurance
Job Number: 17204804
CTG's premier global client in Myerstown, PA has a 12-month contract assignment for Product Quality Assurance in the Pharmaceutical Industry. There is the potential for extension after the initial contract period.
The W2 hourly pay rate will be $24.00/hr.
This is a second shift position with a starting time in the 2-4pm time period.
Major Contributing Activities:
• Perform standard qualitative and quantitative analysis on: purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures of the company, the National Formulary (NF) and the United States Pharmacopoeia (USP).
• Utilize standard "bench" chemistry technique as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc.
• Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms.
• Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary.
• Perform routine analytical testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards.
• Adhere to the pertinent aspects of Corporate and plant safety programs and adhering to GMP’s, ISO standards or other regulations.
• Assist in investigating non-compliance investigations.
• Assist with troubleshooting analytical methodology and instrumentation malfunctions.
• Perform special assignments as directed by supervisor.
• Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology (e.g. equipment and room cleaning validation).
• If assigned to the QA Receiving area, develop specifications for packaging components and prepare final specification sheets for new, revised, or updated components in conjunction with packaging departments, other company facilities and component vendors.
• Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required.
• Knowledge, practical application, and understanding of analytical chemistry is necessary to perform the functions of this position.
• Demonstrated capability for communicating ideas, concepts, and work results effectively to colleagues and supervision.
• Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment is required.
• Must demonstrate initiative and a willingness to learn.
• Good working knowledge of advanced laboratory instrumentation and personal computer skills are required;
• Experience in wet analytical methods and instrumentation techniques preferred; HPLC, UV, GC, IR, AA, TOC, and Dissolution preferred.
• A working knowledge of organic chemistry, statistics, data processing and good manufacturing practices is desirable.
• A thorough understanding of National Formulary (NF); United States Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures preferred.
• Competencies required: analytical problem solving, alertness, work within established policies and procedures, commitment to task, decisiveness, effective written and interpretive communication skills, and organization and planning skills.
• At least 1 year of lab experience preferred:
• Assigned within the lab: bench chemistry or lab experience preferred. ;
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Quality Assurance (QA) / Quality Control (QC)