Job:Quality Assurance (QA) / Quality Control (QC)-
Education Level:Bachelor's Degree (±16 years)
CTG Inc. has been a highly respected provider of contract personnel throughout the United States for more than fifty years.
Currently, our valued client in Berkeley, CA has an opening for aConformance Specialist. This position is a 12-month contract, with the potential for continuation after the initial contract.
The maximum W2 hourly pay rate is $50/hr., based on experience and ability.
Conformance Specialist - Responsible for the investigation of discrepancies observed in thecompany's Supply Center.
POSITION DUTIES & RESPONSIBILITIES
• Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.
• Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement.
• Determine the breadth of discrepancies and ensure appropriate Stakeholders in other organizations are made aware of a potential similar issues in their areas.
• Influences direction of investigations and communicates with all levels of employees.
• Write concise, accurate and effective discrepancy reports that meet compliance expectations.
• Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition.
• Use the Discrepancy Management system/database at an expert level to perform data entry and data mining, in the support of both investigations and report-outs.
• B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.
• Minimum 6 years of experience in pharmaceutical manufacturing
• Experience in performing investigation type work
• Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.
• Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
• Strong analytical skills to identify root causes and prepare balanced decisions
• Ability to communicate with cross-functional partners to satisfy compliance requirements and meet production goals, while resolving discrepancies.
• Excellent oral and written communication skills, as report-writing is a key aspect of the position.
• Demonstrated ability to understand basic functionality of equipment / systems and supporting utility services.
If interested, apply below or send your resume to Gary McAfee at firstname.lastname@example.org. Please reference job #19206909 in the subject line.
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 (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
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 in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace 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.