Quality Associate cGMP
4.
2 San Pedro, CA San Pedro, CA Full-time Full-time $25 - $27 an hour $25 - $27 an hour 5 days ago 5 days ago 5 days ago We have an opportunity for a cGMP Quality Associate to join our team.
This candidate must have an overall understanding of dietary supplements/cosmetics, specifically 21 CFR part 111, current Good Manufacturing Practice (GMP) in manufacturing, packaging, labeling, or holding & distributing operations for dietary supplements.
Established in 1980, Sports Research is one of the largest privately held Health and Wellness brands in the United States.
The ideal candidate will have a doer personality.
A problem solver to find gaps and weaknesses in our Quality System for holding an distribution of dietary supplements.
They will create procedures to improve productivity and clarity of the system.
You will work cross departmentally to understand and upgrade processes.
Organization is one of your attributes.
You will work closely with our Customer Experience Team to research and resolve customer complaints.
Additionally, you will assist in receipt and release of finished products at the warehouse.
Essential Duties and
Responsibilities:
Creating, maintaining and updating Standard Operating Procedures (SOP's) in the Quality Department.
Main focus with warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns, specifically:
Subpart G - Components, Packaging, and Label Control Subpart L - Packaging and Labeling Control System Subpart M - Holding and Distributing Subpart N - Returns Subpart O - Complaints Works with the Customer Experience Team on closing customer complaints including initiating investigations, root cause analysis and complaint resolution (CAPA Corrective and/or Preventive Actions).
Communicate efficiently and effectively to the appropriate Quality Team member(s) all complaints received that involve contract manufacturer's defects.
Communicate any adverse events that fall outside of the established threshold to the Quality Manager and the Executive Team.
Immediately report any Serious Adverse Event to the Quality Manager and the Executive Team.
Review receiving records from warehouse personnel and accurately verify and record all incoming finished goods as per SOPs Inspect incoming materials for damage.
Photograph and record any damage on receiving paperwork.
Notify appropriate parties as per SOP.
Identify any product defects and determine how to resolve the issue and immediately report to the Quality Manager and the Warehouse Management Team.
Approve incoming materials by confirming specifications and/or conducting a visual inspection.
Recommend product for release and/or and rejection.
Works with Quality Control Associate on retain cage management, including destruction of expired products.
Works with Warehouse and Quality Team on product returns and deposition.
Performs other Quality related duties as needed.
Qualifications & Required Skills:
Minimum of 2
years' experience in Quality Assurance or Quality Control in cosmetics, dietary supplements, pharmaceuticals, or food manufacturing.
Minimum of 2
years' experience in customer service.
Bachelor's degree preferred.
Experience with ISO Certified Laboratories and using Standard Operating Procedures (SOP's) preferred.
Knowledge and experience with data management and Quality Control systems preferred.
Proficient with Microsoft Office Suite.
Formatting documents is a plus.
Monday.
com and Zendesk experience is a plus.
Ability to maintain confidentiality and work with sensitive documents.
Interpersonal skills - ability to interact well with colleagues at all levels.
Strong organizational skills.
Adapts to changing priorities effectively.
Ability to collaboratively as well as independently depending on assignment.
Strong analytical and problem-solving skills.
Knowledge of cGMP regulations and industry standard guidelines for electronic records (21 CFR Part 111).
Education courses can be provided if needed.
Ability to manage multiple projects at one time.
Excellent verbal and written communication skills.
Bilingual in English/Spanish is a plus.
List of references required.
Physical Requirements:
This role requires working at both San Pedro, CA headquarters and Torrance, CA warehouse locations based upon current needs in the Quality Department.
May be required to sit and stand for extended periods of time Due to the open environment of the warehouse, must be able to work in various weather and temperature conditions to include heat, humidity and cold.
Must be able to lift 50 pounds.
Sports Research is an equal opportunity employer committed to providing a diverse environment Job Type:
Full-time Pay:
$25.
00 - $27.
00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible schedule Health insurance Life insurance Paid time off Parental leave Vision insurance Experience level:
2 years Schedule:
8 hour shift Monday to Friday Work setting:
In-person Office Warehouse Application Question(s):
Is the rate range within your requirements? Is your background in cGMP (required)? Are you comfortable working in office/warehouse 4 days a week and 1 work from home? Do you have a background specifically in 21 CFR part 111, current Good Manufacturing Practice (GMP) in manufacturing, packaging, labeling, or holding & distributing operations for dietary supplements? Language:
Spanish (not required) (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
2 San Pedro, CA San Pedro, CA Full-time Full-time $25 - $27 an hour $25 - $27 an hour 5 days ago 5 days ago 5 days ago We have an opportunity for a cGMP Quality Associate to join our team.
This candidate must have an overall understanding of dietary supplements/cosmetics, specifically 21 CFR part 111, current Good Manufacturing Practice (GMP) in manufacturing, packaging, labeling, or holding & distributing operations for dietary supplements.
Established in 1980, Sports Research is one of the largest privately held Health and Wellness brands in the United States.
The ideal candidate will have a doer personality.
A problem solver to find gaps and weaknesses in our Quality System for holding an distribution of dietary supplements.
They will create procedures to improve productivity and clarity of the system.
You will work cross departmentally to understand and upgrade processes.
Organization is one of your attributes.
You will work closely with our Customer Experience Team to research and resolve customer complaints.
Additionally, you will assist in receipt and release of finished products at the warehouse.
Essential Duties and
Responsibilities:
Creating, maintaining and updating Standard Operating Procedures (SOP's) in the Quality Department.
Main focus with warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns, specifically:
Subpart G - Components, Packaging, and Label Control Subpart L - Packaging and Labeling Control System Subpart M - Holding and Distributing Subpart N - Returns Subpart O - Complaints Works with the Customer Experience Team on closing customer complaints including initiating investigations, root cause analysis and complaint resolution (CAPA Corrective and/or Preventive Actions).
Communicate efficiently and effectively to the appropriate Quality Team member(s) all complaints received that involve contract manufacturer's defects.
Communicate any adverse events that fall outside of the established threshold to the Quality Manager and the Executive Team.
Immediately report any Serious Adverse Event to the Quality Manager and the Executive Team.
Review receiving records from warehouse personnel and accurately verify and record all incoming finished goods as per SOPs Inspect incoming materials for damage.
Photograph and record any damage on receiving paperwork.
Notify appropriate parties as per SOP.
Identify any product defects and determine how to resolve the issue and immediately report to the Quality Manager and the Warehouse Management Team.
Approve incoming materials by confirming specifications and/or conducting a visual inspection.
Recommend product for release and/or and rejection.
Works with Quality Control Associate on retain cage management, including destruction of expired products.
Works with Warehouse and Quality Team on product returns and deposition.
Performs other Quality related duties as needed.
Qualifications & Required Skills:
Minimum of 2
years' experience in Quality Assurance or Quality Control in cosmetics, dietary supplements, pharmaceuticals, or food manufacturing.
Minimum of 2
years' experience in customer service.
Bachelor's degree preferred.
Experience with ISO Certified Laboratories and using Standard Operating Procedures (SOP's) preferred.
Knowledge and experience with data management and Quality Control systems preferred.
Proficient with Microsoft Office Suite.
Formatting documents is a plus.
Monday.
com and Zendesk experience is a plus.
Ability to maintain confidentiality and work with sensitive documents.
Interpersonal skills - ability to interact well with colleagues at all levels.
Strong organizational skills.
Adapts to changing priorities effectively.
Ability to collaboratively as well as independently depending on assignment.
Strong analytical and problem-solving skills.
Knowledge of cGMP regulations and industry standard guidelines for electronic records (21 CFR Part 111).
Education courses can be provided if needed.
Ability to manage multiple projects at one time.
Excellent verbal and written communication skills.
Bilingual in English/Spanish is a plus.
List of references required.
Physical Requirements:
This role requires working at both San Pedro, CA headquarters and Torrance, CA warehouse locations based upon current needs in the Quality Department.
May be required to sit and stand for extended periods of time Due to the open environment of the warehouse, must be able to work in various weather and temperature conditions to include heat, humidity and cold.
Must be able to lift 50 pounds.
Sports Research is an equal opportunity employer committed to providing a diverse environment Job Type:
Full-time Pay:
$25.
00 - $27.
00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible schedule Health insurance Life insurance Paid time off Parental leave Vision insurance Experience level:
2 years Schedule:
8 hour shift Monday to Friday Work setting:
In-person Office Warehouse Application Question(s):
Is the rate range within your requirements? Is your background in cGMP (required)? Are you comfortable working in office/warehouse 4 days a week and 1 work from home? Do you have a background specifically in 21 CFR part 111, current Good Manufacturing Practice (GMP) in manufacturing, packaging, labeling, or holding & distributing operations for dietary supplements? Language:
Spanish (not required) (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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