Quality Control Analyst
Bloomington, IN Top 3 must haves:
Top Technical skills needed
- Local candidate.
- Comfortable with routine testing. Mixing chemicals together and using analytical instrumentation like pH meters, balances, density meters.
- Follows procedures as written without deviating.
- Good working with small items.
- Comfortable with software systems and using lab instrumentation.
- Knowledge of general Chemistry techniques.
Conduct specific biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and may include environmental monitoring programs. Essential Duties and Responsibilities
- Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.
- Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Write exception documents.
- Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- May perform equipment maintenance and calibrations as required.
- May perform other duties as assigned.
Education and/or Experience
- Ability to handle multiple tasks concurrently, be detail oriented and be able to complete tasks in a timely fashion.
- Must have basic understanding of laboratory instrumentation.
- Must be able to communicate effectively with supervisors and peers and work effectively and efficiently in a team environment.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Knowledge of cGMP manufacturing.
- Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
- Knowledge of basic chemical and biological safety procedures.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must have passion to innovate and drive for solutions.
- Must display personal accountability for results and integrity.
- Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 year's experience. 4 year degree within sciences is required
- Appropriate additional certifications may be required pursuant to state or federal regulatory requirements
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
Posting ID: 559413692Posted: 2020-07-14