At Microbiology & Quality Associates (MQA), we are always looking for new members to join our team and would like to hear from you. We are currently seeking a Manufacturing Services Manager, Validation & Calibration Services Manager, Chemistry Lab Technician, Janitor, Inside Sales Associate, and Lab Technician for Microbiology and Environmental Monitoring.
If you are interested in applying, please indicate which position you would like to be considered for and forward your resume to HR@microqa.com.
Manufacturing Services Manager
Microbiology & Quality Associates, Inc. (MQA) a CRO and CMO organization located in Concord, CA is recruiting for a Manufacturing Services Manager to lead the manufacturing services group. MQA offers custom manufacturing services to biotechnology and pharmaceutical companies. Services offered includes non-GMP and GMP services in the areas of GMP master cell bank preparation, small aseptic filling for non-human use and other custom project. The person we are looking for must have a diverse experience in biopharma, entrepreneurial attitude, knowledge of FDA regulations and hard working.
Manage the daily and long term objectives of the Manufacturing Services group. The Manager is to manage the aseptic filling areas, reagent manufacturing, media & equipment prep and other and manufacturing projects. Conduct departmental operations in compliance with GMPs, SOPs and FDA guidelines as needed. Responsible for GMP, environmental health and safety procedure awareness, and compliance within the respective area.
The Manager main duties are to ensure timeliness of completing client orders in the allotted times, ensure meeting client requirements, safety and GMP compliance when applicable. Develops or oversee development of new manufacturing processes based on scientific literature or compendia protocols. Ensure efficiency and financial success of the manufacturing services group by maximizing efficiencies, keeping cost down and having a “what-ever it takes” attitude to make things happen with excellent quality. The manager is responsible to communicate with clients in a professional manner to discuss projects, resolve issues and ensure clients are happy. Coordinate testing and lab activities to ensure product quality and release. Monitors and checks operation, calibration, and service condition of equipment along with monitoring and maintaining supplies. Complies with procedures and adhere to documentation practices in accordance with MQA policies. Other duties will be assigned as needed.
The work includes the following activities:
• Manage Manufacturing Services operations and personnel
• Design efficient manufacturing processes
• Ensure safety and GMP compliance as needed
• Communicate with clients
• Coordinate or perform validation of equipment
• Ensure efficient operations
• Prepare production batch records, protocols and procedures as needed;
• Ensure personnel training, performance and mentoring;
• Develops or oversee development of processes as needed.
. Works with all groups to ensure the work is done and product is release on time with excellent quality.
• Other duties as assigned;
BS or higher in Science with a concentration in microbiology, with at least 5 years experience, preferably in biophrama and GMP environment. Extensive hands-on knowledge of aseptic operations, cell culture (mammalian and bacterial), aseptic filling, QA and microbiology. Excellent communication skills.
Validation & Calibration Services Manager
MQA Validation and Calibration services (VCS), a division of Microbiology & Quality Associates, Inc., located in Concord, CA is looking for a hands-on Manager for the VCS group. The position is FT. MQA VCS group provides GMP validation and calibration services for in-house and to companies such as medical device, biopharma, compound pharmacies and semiconductors The VCS Manager will lead the group to ensure our validation and calibration services are completed in compliance with GMP, safely, efficiently and meet our client requirements.
1. Manage the VCS validation and calibration operations.
2. Manage and provide training to VCS team members. Currently the team consist of 3 associates, but can increase based on projects.
3. Prepare, review and approve in-house SOP’s, protocols and reports for in-house or clients.
4. Work with clients in validation and calibration activities.
5. Schedule outside VCS activities with clients.
6. Ensure all work and procedures comply with GMP and ISO 17025 quality requirements.
7. Manage MQA validation and calibration program.
8. Represent MQA in client audits and FDA inspections.
1. Minimum of BS degree in science or Engineering.
2. GMP experience.
3. At least 5 years hands on experience in calibration of equipment, cleaning validation, facility clean room qualification, validation of temperature controlled chambers, steam sterilizer, oven, manufacturing and laboratory equipment validation and critical utilities.
4. At least 2 years’ experience leading and supervising people in a GMP environment.
5. Experience managing validation projects.
6 Hands-on experience preparing validation protocols.
7. Legal to work in the US. Pass E-Verify system, background and drug test.
8. Ability to work as part of team and independently.
9. Excellent English skills: written and spoken
10. Experience resolving protocol deviation issues.
11. Excellent attention to details
12. Positive and flexible attitude and team work
13. Driver license
14. Experience in calibration of equipment such as temperature gauges, pressure gauges and flow meters. Also, experience with fume hood, HEPA filter and BSC certifications will be a plus.
Chemistry Lab Technician
Employment type: full-time
MQA Laboratories a contract laboratory located in Concord, California is accepting applications for a temporary Full Time Chemistry Lab Technician. MQA is a growing CRO & CMO providing services to life sciences companies across the US. The individual will be working in the Bioanalytical laboratory testing raw materials, client samples and validation of methods under supervision.
– Perform testing of raw materials and samples per client requirements or regulatory requirements (ICH, USP or EU).
– Prepare SOPs for equipment and test procedures.
– Prepare protocols and reports for testing client samples.
– Maintains equipment in accordance with SOP and maintenance schedules.
– Ensures lab safety by following procedures.
– B.S. in biochemistry or chemistry. Must have classes in organic chemistry, analytical chemistry, inorganic, physical chemistry
– 2+ years of biopharmaceutical/ life sciences experience in the area of GMP quality control testing or analytical development.
– Excellent hands-on knowledge of analytical techniques (AKTA chromatography system, AAA, MS, HPLC, GC-FID, GC-TCID, GC-MS, EA, FTIR, NIR, Karl Fisher, etc) and wet chemistry used for raw material and product quality control.
– Full understanding and hands-on knowledge of the USP, EP, JP and ICH requirements for raw materials and finished product.
– Experience developing, validation and implementing chemical assays for GMP testing of raw materials and finished product.
– Experience troubleshooting and minor fixed for HPLC, GC and other equipment.
– Knowledge of cGMP and filing regulations, practices, and trends pertaining to testing of biopharmaceuticals, cosmetics and nutraceuticals.
– Excellent English written and verbal communication skills.
– Legal to work in the US. Company won’t sponsor visas.
– Able to make decisions independently and effectively.
– Good knowledge of statistics and MS Office.
– Team member
– Attention to detail
Lab Technician for Microbiology & Environmental Monitoring
Compensation: Based on experience
Employment type: full-time
MQA Laboratories a contract laboratory located in Concord, Ca is looking for laboratory technicians to perform environmental monitoring functions at client facilities and microbiology testing in the Microbiology lab. The position is a TEMPORARY Full time depending on the project needs. The position will last at least 3 months with potential for regular employment. The schedule will be M-F 7am to 3:30pm, but you must be able to work flexible hours, including different shifts and weekends. At time the starting hour is 5am and will require OT.
1) perform air sampling in clean room areas,
2) collect and test microbial and chemical water samples
3) collect and test compressed gas samples
4) read plates
5) perform basic microbiology test such plate counts
6) report results in test records,
7) enter results in databases
8) follow FDA GMP practices and safety rules.
1. AA or BS in microbiology or related science
2. At least 1 year experience in a GMP microbiology lab performing similar duties
3. At least 1 year hands-on experience performing environmental monitoring of clean room areas
4. Experience working in clean rooms
5. Attention to detail
6. GMP experience
7. Flexible hours
8. Legal to work in US, must pass E-verify
9. Must pass background check and drug test
10. Fluent in English (written and spoken)
11. Basic computer skills
12. Must have own transportation
13. Must be able to stand, bend and move for long periods of time collecting samples in clean rooms, sometimes 12 hrs a day.
14. Must be able to gown in clean room suits and be in a clean room environment for long period of time.
15. Must be able to professionally interact with clients.
16. Must have a valid driver license, good driving record and own transportation to get to work at different times.