Regulatory & Quality Control Jobs

Someone once said that something worth doing is worth doing well. Do you appreciate a quality job? The bioscience industry is highly regulated; they need people to make sure rules are followed, and quality standards are met so products are safe.

If you see a Regulatory or Quality Control job title that looks interesting, click it to learn more about the job, required education, the salary and work environment.

Overview

Annual salary range: $30,000 – $160,000+

Education range: high school diploma – PhD/JD

Factoid: The FDA regulates the use of medical devices, from tongue depressors to MRI machines to glucose testers, which means every medical device must undergo a series of trials and tests to make sure it’s safe and performs as it should.

Entry Level Jobs

Assay Analyst (AKA Quality Assurance Analyst, Quality Control Analyst)

Description:
Follows Standard Operating Procedures to perform assays on in-process and final product test samples; participates in modification of assay procedures. Performs laboratory cultures, assays, and tests; sets up, calibrates, and operates equipment; records data; adhering to guidelines and regulations.

Education:
A.S. degree and 2 years experience in biomanufacturing or B.S. degree in scientific discipline may be required.

Salary Range:
$35,100-$54,000; Average: $44,452

Work Environment:
This job is found in the Diagnostic, Medical Device and Pharmaceutical industry.

Calibration Technician

Description:
Performs maintenance, testing, troubleshooting, metrology, calibration and repairs on analytical equipment and instrumentation; performs validation studies and analyzes results; maintains spare parts inventory.

Education:
A.S. and 4-7 years related work experience or B.S. and 2-3 years experience

Salary Range:
$38,000 – $75,600; Average: $52,000

Work Environment:
This job is found in the Medical Device industry.

Document Control Specialist / Coordinator

Description:
Responsible for proofing all domestic and international product labeling and ensuring the integrity of the documents. Coordinates all activities related to providing required documentation and implementing documentation systems coordinates review and revision of procedures, specifications, and forms

Education:
AA/AS degree required; BA/BS degree in related field and 0-4 years experience preferred

Salary Range:
$39,800-70,200; Average: $54,000

Work Environment:
This job is found in the Diagnostic, Medical Device and Pharmaceutical industry.

Mid Level Jobs

Laboratory Analyst

Description:
Conducts analysis of raw materials, in-process samples and finished formulations and products according to Standard Operating Procedures; calibrates and maintains chemistry and microbiology lab equipment; compiles and analyzes data for test procedure documentation

Education:
A.S. in related scientific discipline and 2-5 years experience in quality assurance; B.S. in scientific discipline/equivalent and 0-4 years experience in quality control systems preferred

Salary Range:
$40,000 – $65,000; Average $46,350

Work Environment:
This job is found in the Pharmaceutical industry.

Manager Regulatory Affairs

Description:
Manages the integrated development process by coordinating project team activities, installing and monitoring project planning functions, and reporting to management; assists in the development of regulatory strategies for projects to ensure multinational registrations consistent with strategic objectives and world-wide regulatory requirements

Education:
BA/BS and 5-7 years of related experience or Master’s with 3-4 years related experience

Salary Range:
$70,700 – $155,000; Average: $85,000

Work Environment:
This job is found in the Diagnostic, Medical Device and Pharmaceutical industry.

Validation Technician (AKA Validation Specialist)

Description:
Develops test validation protocols according to all standards; compiles and analyzes validation data; prepares reports and recommends improvements; develops quality standards for processing materials into products; designs and implements inspection, testing, and evaluation procedures; prepares documentation for inspection testing procedures; verifies accuracy of existing and new equipment.

Education:
B.S. in scientific, engineering, or related technical field and 3 years experience in a regulated industry; knowledge of current industry practices, and current Good Manufacturing Practice

Salary Range:
$40,000 – 80,000; Average: $67,000

Work Environment:
This job is found in the Pharmaceutical industry.

Advanced Level Jobs

Director of Quality Control and Assurance

Description:
Responsible for short and long term goals of quality control; formulates and recommends quality assurance policies and programs; develops quality control and quality assurance budgets; directs quality control staff and daily operations, manages Good Manufacturing Practice program; assures that finished products comply with government and company standards.

Education:
BS or MS in chemistry, Chemical Engineering, Food Science, or other related scientific discipline with 10-15 years related experience, PhD preferred and 6-10+years experience in chemistry, quality control and/or laboratory management positions

Salary Range:
$47,150-$115,400; Average: $82,350

Work Environment:
This job is found in the Diagnostic, Medical Device and Pharmaceutical industry.

Director of Regulatory Affairs

Description:
Plans and directs long and short-term regulatory activities; develops and implements strategies for approval of regulatory submission; negotiates with outside agencies to resolve regulatory issues; stays current with changes in regulatory requirements

Education:
BS/MS in related scientific discipline with 10-15 years related experience, PhD preferred and 10 years experience

Salary Range:
$70,700-$155,000; Average: $113,817

Work Environment:
This job is found in the Diagnostic, Medical Device and Pharmaceutical industry.

Legal Counsel

Description:
Special Counsel services include customized staffing and project management for e-discovery and document review projects of any size and location, as well as providing experienced legal professionals for general workload management, litigation support, and business transaction support.

Education:
JD and 5-10 years experience

Salary Range:
$44,400 – $166,400; Average: $76,000

Work Environment:
This job is found in the Medical Device industry.

Case Study

Alison – Asset Ware

“Owens Community College’s biomedical program helped me land a great job.”

AssetWare is a company helping to meet the challenges presented by the movement of medical records and ordering systems from paper to electronic records. The challenge is equal parts technology and behavior change, and medical professionals need support as they learn and implement these new and critical information systems. AssetWare and companies like it are facing shortages of skilled workers – so much so that they have brought in people from out of state to support Toledo area hospitals in their conversion to electronic records.

Allison had experience with computers and in the medical field, and being a Toledo native she felt that she could help to meet this need. She is an Analyst for AssetWare, working with doctors and nurses on the floor at hospitals across Northwest Ohio, making sure that they understand the charting and ordering system and its capabilities.

Allison worked as a technology/computers teacher at an elementary school for about 8 years when budget cuts limited her opportunities for advancement. She had heard about plentiful jobs in healthcare so she studied to become a phlebotomist, only to discover how difficult it was to get a phlebotomy job that paid well enough. Being very comfortable around information technology from her teaching days, and with an awareness of medical issues from the phlebotomy program integrating the two seemed a good fit – but she still had much to learn about the particular technologies and about other areas of the medical field.

She attended Owens Community College’s Biomedical program and was able to take her medical knowledge to the next level, apply her technology capabilities and fill a real need in the healthcare community. She praised Owens for offering her the opportunity to learn in a flexible manner, and for creating connections to the employer community.

“I am using my computer background in ways that never occurred to me. I did basic technology, then I did basic healthcare. In both of those arenas I was limited in what I could do and what I would be able to earn. But the training program helped me to build both of these skills into something a little more meaningful”.

When asked to offer advice to people thinking of moving in this direction, Alison encourages students to look beyond the obvious. “Yes, there are jobs in the medical field, but it’s not all doctors and nurses. I found a great niche in Medical Information Technology but there are many other opportunities”.